VenaSeal Spectrum: Global Post-Market Randomized Controlled Trial

Global, Post-Market, Prospective, Multi-Center, Randomized Controlled Trial of the VenaSeal™ Closure System vs. Surgical Stripping or Endothermal Ablation (ETA) for the Treatment of Early & Advanced Stage Superficial Venous Disease

Global, Post-Market, Prospective, Multi-Center, Randomized Controlled Trial of the VenaSeal™ Closure System vs. Surgical Stripping or Endothermal Ablation (ETA) for the Treatment of Early and Advanced Stage Superficial Venous Disease

Study Overview

• Status: Terminated
• Conditions: Venous Reflux
• Intervention / Treatment: Device: Endothermal Ablation (ETA); Procedure: Surgical Stripping; Device: VenaSeal™ System

Detailed Description

The study is designed with two randomized studies and one single arm study.

Two randomized studies are for CEAP 2-5 subjects:

1. VenaSeal vs. Surgical Stripping Study (outside of the United States only)
2. VenaSeal vs. ETA Study

The single arm study is for CEAP 6 subjects with active venous leg ulcers (VLU):

1. VLU Study

• Study Type: Interventional
• Enrollment (Actual): 506
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Australia
  • Birtinya, Australia, 4575
    • Sunshine Coast University Hospital
  • Wollongong, Australia
    • Wollongong Hospital
• Canada
  • Ontario
    • Toronto, Ontario, Canada, M4L 3Y3
      • East Toronto Vascular Clinic
• France
  • Lyon, France, 69006
    • Clinique du Parc
  • Toulouse, France
    • Clinique Pasteur
  • DIjon Cedex
    • Dijon, DIjon Cedex, France, 21079
      • CHU Dijon Bourgogne
• Germany
  • Halle, Germany, 06108
    • Praxis fur Innere Medizin und Gefäβkrankheiten
• Italy
  • Milan, Italy, 20121
    • Ospedale Fatebenefratelli e Oftalmico
  • Padua, Italy, 35127
    • Azienda Ospedaliera di Padova Ospendale Sant' Antonio
• Netherlands
  • Arnhem, Netherlands, 6815
    • Rijnstate - Locatie Arnhem
• South Korea
  • Seoul, South Korea
    • Gangnam Severance Hospital
  • Seoul, South Korea, 110-744
    • Seoul National University Hospital
  • Seoul, South Korea, 137-701
    • Seoul Saint Mary's Hospital
  • Seoul, South Korea, 143-729
    • Konkuk University Medical Center
• Spain
  • Granada, Spain, 18016
    • Complejo Hospitalario Universitario Granada (Hospital Campus de la Salud)
  • Madrid, Spain, 28023
    • Sanitas Hospital Universitario La Zarzuela
• United Kingdom
  • Bedford, United Kingdom, MK42 9DJ
    • Bedfordshire Hospitals NHS Foundation Trust
  • Cambridge, United Kingdom, CB2 0QQ
    • Cambridge University Hospitals NHS Foundation Trust - Addenbrooke's Hospital
  • Harrow, United Kingdom, HA1 3UJ
    • West London Vascular and Interventional Centre
  • London, United Kingdom, W12 0HS
    • Imperial College Healthcare NHS Trust - Charing Cross Hospital
• United States
  • Arizona
    • Prescott Valley, Arizona, United States, 86314-2255
      • Yavapai Regional Medical Center
    • Tucson, Arizona, United States, 85718
      • Pima Heart and Vascular
  • California
    • Fresno, California, United States, 93701
      • Valley Vascular Surgical Associates
  • Connecticut
    • Darien, Connecticut, United States, 06820
      • Vascular Care Connecticut
    • New Haven, Connecticut, United States, 06510
      • Yale School of Medicine
  • District of Columbia
    • Washington D.C., District of Columbia, United States, 20007-2113
      • Georgetown University Medical Center
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
    • Wellesley, Massachusetts, United States, 02482
      • Vascular Care Group
  • New York
    • New York, New York, United States, 10024
      • New York-Presbyterian Hospital/Weill Cornell Medical Center
  • Ohio
    • Columbus, Ohio, United States, 43214
      • OhioHealth Riverside Methodist Hospital
  • Texas
    • Houston, Texas, United States, 77034
      • Orion Medical
  • Washington
    • Bellevue, Washington, United States, 98004-4623
      • Lake Washington Vascular

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Patient is ≥18 years of age
2. Patient has venous reflux in superficial truncal vein(s) (e.g., GSV, SSV, accessory saphenous veins) with CEAP 2 (symptomatic) or CEAP 3, 4a, 4b, 5, 6, appropriate for treatment, as confirmed by Duplex Ultrasound (DUS)

3. Eligibility for treatment:

   • VenaSeal vs ETA Study: Patient is eligible for treatment with the VenaSeal™ system and ETA
   • VenaSeal vs Surgical Stripping Study: Patient is eligible for treatment with the VenaSeal™ system and surgical stripping
   • VLU Study: patients should be eligible for treatment with the VenaSeal™ system
4. Treatable refluxing segment of target vein(s) 10 cm in length or longer
5. Patient has a target vein diameter of ≥3 mm throughout the intended treated segment of the target vein as measured by DUS while patient is standing
6. Patient is willing and capable of complying with specified follow-up evaluations at the specified times
7. Patient has an ability to understand the requirements of the study and to provide informed consent

Exclusion Criteria:

1. Patient has a known history of allergic sensitivities (including but not limited to cyanoacrylate adhesives), or any other condition, which in the opinion of the investigator may make the patient more susceptible to cyanoacrylate adhesive hypersensitivity
2. Patient has known deep vein obstruction in the target limb, as identified by the site's standard of care
3. Patient has abnormal pulse exam or ABI <0.8
4. Patient has acute superficial thrombophlebitis
5. Patient requires any non-target vein treatments in the contralateral or ipsilateral limb, or any other surgical procedure up tp 30 days pre-procedure and through 3 months post-procedure
6. Patient has any co-morbid conditions, which in the investigator's opinion may interfere with the patient's compliance with study visits and procedures, or may confound interpretation of study data (e.g., congestive heart failure Class III and IV, non-ambulatory patients, severe hepatic dysfunction, life expectancy < 1 year)

7. IFU contraindications:

   • VenaSeal vs. ETA Study: Patient has VenaSeal™ system and/or ETA product's IFU contraindication(s)
   • VenaSeal vs Surgical Stripping Study: Patient has surgical stripping and/or VenaSeal™ system IFU contraindication(s)
   • VLU Study: Patient has VenaSeal™ system IFU contraindication(s)
8. Patient is non-ambulatory
9. Patient is a female of childbearing potential who may be pregnant or breastfeeding at the time of the index procedure
10. Patient belongs to a vulnerable population per investigator's judgment or patient has any kind of disorder that compromises his/her ability to give written informed consent and/or to comply with study procedures
11. Patient is currently participating in an investigational drug or device study when the data collected could be conflicting or biased due to participation in another study
12. Patient has documented COVID-19 infection currently or within the past 3 months. Patient is not completely recovered from past COVID-19 infection, per physician's discretion.
13. VLU Study: Patient has target ulceration identified to be of non-venous etiology, as confirmed by the independent core laboratory
14. VLU Study: Patient has target circumferential ulceration that cannot be captured in a single photograph (any ulcer curvature around the leg that goes out of sight)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Randomized study VenaSeal™ System versus Endothermal Ablation (ETA): VenaSeal™ System; CEAP 2-5 subjects will be randomized to VenaSeal™ System vs. ETA	Device: VenaSeal™ System; The VenaSeal™ System is the non-tumescent, non-thermal, non-sclerosant device that uses a proprietary medical adhesive delivered endovenously to close the vein.
Active Comparator: Randomized study VenaSeal™ System versus Endothermal Ablation (ETA): ETA; CEAP 2-5 subjects will be randomized to VenaSeal™ System vs. ETA	Device: Endothermal Ablation (ETA); ETA includes EVLA that uses laser or RFA that uses radiofrequency heating to close the vein. Heat is applied in both EVLA and RFA therapies to close the vein. Subject can be treated with either EVLA or RFA if randomized to ETA arm per site's standard practice.; Other Names: Radiofrequency ablation (RFA); Endovenous laser ablation (EVLA)
Experimental: Randomized study VenaSeal™ System versus Surgical Stripping: VenaSeal™ System; CEAP 2-5 subjects will be randomized to VenaSeal™ System vs. Surgical Stripping	Device: VenaSeal™ System; The VenaSeal™ System is the non-tumescent, non-thermal, non-sclerosant device that uses a proprietary medical adhesive delivered endovenously to close the vein.
Active Comparator: Randomized study VenaSeal™ System versus Surgical Stripping: Surgical Stripping; CEAP 2-5 subjects will be randomized to VenaSeal™ System vs. Surgical Stripping	Procedure: Surgical Stripping; Surgical stripping involves stripping (removal) of the diseased vein via surgical procedures.
Experimental: Single arm Venous Leg Ulcer (VLU) Study: VenaSeal™ System; CEAP 6 active leg ulcer subjects will not be randomized to a comparator, all subjects will be treated with VenaSeal™ System	Device: VenaSeal™ System; The VenaSeal™ System is the non-tumescent, non-thermal, non-sclerosant device that uses a proprietary medical adhesive delivered endovenously to close the vein.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Primary Endpoint: Peri-procedural Patient Satisfaction as Measured by a Validated, Patient-centered Venous Treatment Satisfaction Questionnaire (VenousTSQe) at 30 Days.	Measured by a validated, patient-centered venous treatment satisfaction questionnaire - early (VenousTSQe). Total score ranges from 0-36, and a higher score means a higher peri-procedural venous treatment satisfaction.	30 days
Randomized Study VenaSeal™ System Versus Surgical Stripping: Primary Endpoint: Peri-procedural Patient Satisfaction as Measured by a Validated, Patient-centered Venous Treatment Satisfaction Questionnaire (VenousTSQe) at 30 Days.	Measured by a validated, patient-centered venous treatment satisfaction questionnaire - early (VenousTSQe). Total score ranges from 0-36, and a higher score means a higher peri-procedural venous treatment satisfaction.	30 days
Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Primary Endpoint: Patient Satisfaction as Measured by a Validated, Patient-centered Venous Treatment Satisfaction Questionnaire (VenousTSQs) at 30 Days.	Measured by a validated, patient-centered venous treatment satisfaction questionnaire - status (VenousTSQs). Total score ranges from 0-36, and a higher score means a higher venous treatment satisfaction.	30 days
Randomized Study VenaSeal™ System Versus Surgical Stripping: Primary Endpoint: Patient Satisfaction as Measured by a Validated, Patient-centered Venous Treatment Satisfaction Questionnaire (VenousTSQs) at 30 Days.	Measured by a validated, patient-centered venous treatment satisfaction questionnaire - status (VenousTSQs). Total score ranges from 0-36, and a higher score means a higher venous treatment satisfaction.	30 days
Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Primary Endpoint: Elimination of Clinically Relevant Superficial Truncal Disease in Each Target Vein at the Time of Index Procedure.	Elimination of clinically relevant superficial truncal disease in each target vein at the time of index procedure as measured by the percentage of target vein length successfully treated.	Post Index procedure, on the day of the procedure immediately following treatment
Randomized Study VenaSeal™ System Versus Surgical Stripping: Primary Endpoint: Elimination of Clinically Relevant Superficial Truncal Disease in Each Target Vein at the Time of Index Procedure.	Elimination of clinically relevant superficial truncal disease in each target vein at the time of index procedure as measured by the percentage of target vein length successfully treated.	Post Index procedure, on the day of the procedure immediately following treatment
Single Arm Venous Leg Ulcer (VLU) Study: Primary Endpoint: Time to Ulcer Healing, Calculated Through Healing Confirmation and Verified by an Independent Core Laboratory Through 12 Months.	Time to ulcer healing reported by using the cumulative incidence probability estimate of the event happening at 12 months, expressed as a percentage. The data values below represent the cumulative incidence probability as a percentage of participants with ulcer healing through 12 months.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Key Secondary Endpoint: Anatomic Closure of the Primary Target Superficial Truncal Vein at 6 Months.	Anatomic closure of the primary target superficial truncal vein, defined as DUS showing vein closure along the entire treated vein segment with no discrete segments of patency exceeding 5 cm after VenaSeal™ system and ETA procedures. Time to lack of anatomic closure was reported by using the Kaplan-Meier survival probability estimate at 6 months expressed as a percentage. The data values below represent the Kaplan-Meier survival probability as a percentage of primary target veins with anatomic closure through 6 months.	6 months
Randomized Study VenaSeal™ System Versus Surgical Stripping: Key Secondary Endpoint: Anatomic Closure of the Primary Target Superficial Truncal Vein at 6 Months.	Anatomic closure of the primary target superficial truncal vein, defined as DUS showing vein closure along the entire treated vein segment with no discrete segments of patency exceeding 5 cm after VenaSeal™ system, or the absence of refluxing or residual primary target vein after surgical stripping procedures. Time to lack of anatomic closure was reported by using the Kaplan-Meier survival probability estimate at 6 months expressed as a percentage. The data values below represent the Kaplan-Meier survival probability as a percentage of primary target veins with anatomic closure through 6 months.	6 months
Single Arm Venous Leg Ulcer (VLU) Study: VenaSeal™ System: Key Secondary Endpoint: Anatomic Closure of the Primary Target Superficial Truncal Vein at 6 Months.	Anatomic closure of the primary target superficial truncal vein, defined as DUS showing vein closure along the entire treated vein segment with no discrete segments of patency exceeding 5 cm after VenaSeal™ system. Time to lack of anatomic closure was reported by using the Kaplan-Meier survival probability estimate at 6 months expressed as a percentage. The data values below represent the Kaplan-Meier survival probability as a percentage of primary target veins with anatomic closure through 6 months.	6 months
Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Key Secondary Endpoint: Time to Return to Work as Reported by the Patient.	Time to return to work reported by using the cumulative incidence probability estimate of the event happening at 30 days, expressed as a percentage. The data values below represent the cumulative incidence probability as the percentage of participants returning to work through 30 days.	30 days
Randomized Study VenaSeal™ System Versus Surgical Stripping: Key Secondary Endpoint: Time to Return to Work as Reported by the Patient.	Time to return to work reported by using the cumulative incidence probability estimate of the event happening at 30 days, expressed as a percentage. The data values below represent the cumulative incidence probability as the percentage of participants returning to work through 30 days.	30 days
Single Arm Venous Leg Ulcer (VLU) Study: VenaSeal™ System: Key Secondary Endpoint: Time to Return to Work as Reported by the Patient.	Time to return to work reported by using the cumulative incidence probability estimate of the event happening at 30 days, expressed as a percentage. The data values below represent the cumulative incidence probability as the percentage of participants returning to work through 30 days.	30 days
Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Anatomic Closure of Primary Target Vein at 30 Days, and 12, 24, 36, 48 and 60 Months.	For subjects treated with the VenaSeal™ system or ETA it is defined as DUS showing vein closure along the entire treated vein segment with no discrete segments of patency exceeding 5 cm. Time to lack of anatomic closure was reported by using the Kaplan-Meier survival probability estimate at 30 days and 12 months, expressed as a percentage. The data values below represent the Kaplan-Meier survival probability as a percentage of primary target veins with anatomic closure through 30 days and 12 months.	30 days and 12 months. Data for additional time points 24, 36, 48 and 60 months will be added to additional outcome measure with next posting as data collection is still ongoing.
Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Anatomic Closure of Primary Target Vein at 30 Days, and 12 Months.	Anatomic closure of the primary target superficial truncal vein, defined as DUS showing vein closure along the entire treated vein segment with no discrete segments of patency exceeding 5 cm after VenaSeal™ system, or the absence of refluxing or residual primary target vein after surgical stripping procedures. Time to lack of anatomic closure was reported by using the Kaplan-Meier survival probability estimate at 30 days and 12 months, expressed as a percentage. The data values below represent the Kaplan-Meier survival probability as a percentage of primary target veins with anatomic closure through 30 days and 12 months.	30 days, 12 months
Single Arm Venous Leg Ulcer (VLU) Study: VenaSeal™ System: Secondary Endpoint: Anatomic Closure of Primary Target Vein at 30 Days, and 12, 24, 36, 48 and 60 Months.	For subjects treated with the VenaSeal™ system it is defined as DUS showing vein closure along the entire treated vein segment with no discrete segments of patency exceeding 5 cm. Time to lack of anatomic closure was reported by using the Kaplan-Meier survival probability estimate at 30 days and 12 months, expressed as a percentage. The data values below represent the Kaplan-Meier survival probability as a percentage of primary target veins with anatomic closure through 30 days and 12 months.	30 days and 12 months. Data for additional time points 24, 36, 48 and 60 months will be added to additional outcome measure with next posting as data collection is still ongoing.
Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Anatomic Closure of Target Vein at 30 Days, and 6, 12, 24, 36, 48 and 60 Months.	For subjects treated with the VenaSeal™ system or ETA this is defined as DUS showing vein closure along the entire treated vein segment with no discrete segments of patency exceeding 5 cm. Time to lack of anatomic closure was reported by using the Kaplan-Meier survival probability estimate at 30 days, 6 months, and 12 months, expressed as a percentage. The data values below represent the Kaplan-Meier survival probability as a percentage of target veins with anatomic closure through 30 days, 6 months, and 12 months.	30 days, and 6, 12 months. Data for additional time points 24, 36, 48 and 60 months will be added to additional outcome measure with next posting as data collection is still ongoing.
Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Anatomic Closure of Target Vein at 30 Days, and 6, 12 Months.	Anatomic closure of target superficial truncal vein defined as DUS showing vein closure along the entire treated vein segment with no discrete segments of patency exceeding 5 cm after VenaSeal™ system, or the absence of refluxing or residual primary target vein after surgical stripping procedures. Time to lack of anatomic closure was reported by using the Kaplan-Meier survival probability estimate at 30 days, 6 months, and 12 months, expressed as a percentage. The data values below represent the Kaplan-Meier survival probability as a percentage of target veins with anatomic closure through 30 days, 6 months, and 12 months.	30 days, 6, 12 months
Single Arm Venous Leg Ulcer (VLU) Study: VenaSeal™ System: Secondary Endpoint: Anatomic Closure of Target Vein at 30 Days, and 6, 12, 24, 36, 48 and 60 Months.	For subjects treated with the VenaSeal™ system this is defined as DUS showing vein closure along the entire treated vein segment with no discrete segments of patency exceeding 5 cm. Time to lack of anatomic closure was reported by using the Kaplan-Meier survival probability estimate at 30 days, 6 months, and 12 months, expressed as a percentage. The data values below represent the Kaplan-Meier survival probability as a percentage of target veins with anatomic closure through 30 days, 6 months, and 12 months.	30 days, and 6, 12 months. Data for additional time points 24, 36, 48 and 60 months will be added to additional outcome measure with next posting as data collection is still ongoing.
Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Technical Success of Each Target Vein Immediately Post-index Procedure.	For subjects treated with the VenaSeal™ system or ETA this is defined as DUS showing vein closure along the entire treated vein segment with no discrete segments of patency exceeding 5 cm.	Post Index procedure, on the day of the procedure immediately following treatment
Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Technical Success of Each Target Vein Immediately Post-index Procedure.	Defined as DUS showing vein closure along the entire treated vein segment with no discrete segments of patency exceeding 5 cm after VenaSeal™ system, or the absence of refluxing or residual vein after surgical stripping procedures.	Post Index procedure, on the day of the procedure immediately following treatment
Single Arm Venous Leg Ulcer (VLU) Study: VenaSeal™ System: Secondary Endpoint: Technical Success of Each Target Vein Immediately Post-index Procedure.	For subjects treated with the VenaSeal™ system this is defined as DUS showing vein closure along the entire treated vein segment with no discrete segments of patency exceeding 5 cm.	Post Index procedure, on the day of the procedure immediately following treatment
Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Reintervention of Any Target Vein (Including Primary Target Vein) Through 12 Months, Assessed at Each Follow-up Visit.		12 months
Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Time to Reintervention of Any Target Vein (Including Primary Target Vein) Through 12 Months.	As measured by the time between the index procedure and the first reintervention procedure. Time to reintervention was reported by using the event free Kaplan-Meier survival probability estimate at 12 months expressed as a percentage. The data values below represent the Kaplan-Meier survival probability as a percentage of target veins without a reintervention through 12 months.	12 months
Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Adverse Events (AEs) Occurring in the Target Limb, Evaluated From Index Procedure Through 12 Months.	Hypersensitivity to VenaSeal™ adhesive, Phlebitis, Granuloma, Endovenous glue induced thrombosis (EGIT) or endovenous heat induced thrombosis (EHIT), Symptomatic deep vein thrombosis (DVT) events.	12 months
Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Adverse Events (AEs) Occurring in the Target Limb, Evaluated From Index Procedure Through 12 Months.	Hypersensitivity to VenaSeal™ adhesive, Phlebitis, Granuloma, Endovenous glue induced thrombosis (EGIT), Symptomatic deep vein thrombosis (DVT) events.	12 months
Single Arm Venous Leg Ulcer (VLU) Study: VenaSeal™ System: Secondary Endpoint: Adverse Events (AEs) Occurring in the Target Limb, Evaluated From Index Procedure Through 12 Months.	Hypersensitivity to VenaSeal™ adhesive, Phlebitis, Granuloma, Endovenous glue induced thrombosis (EGIT), Symptomatic deep vein thrombosis (DVT) events.	12 months
Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Additional Events Evaluated Through 12 Months.	Symptomatic pulmonary embolism (PE), Serious adverse events (SAEs).	12 months
Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Number and Type of Adjunctive Treatments Conducted Through 12 Months Post-index Procedure.		12 months
Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Number and Type of Adjunctive Treatments Conducted Through 12 Months Post-index Procedure.		12 months
Single Arm Venous Leg Ulcer (VLU) Study: Secondary Endpoint: Number and Type of Adjunctive Treatments Conducted Through 12 Months Post-index Procedure.		12 months
Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Healthcare Utilization Related to the Target Limb VRD.	Determined by the number of healthcare visits conducted, and other health-related resources utilized (e.g., home healthcare services) between study visits through 12 months.	12 months
Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Procedures, Tests and Treatment of AEs Related to the Treatment Modality or Index Procedure Through 12 Months.		12 months
Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Time to Return to Normal Activities as Reported by the Patients.	Time to return to normal activities reported by using the cumulative incidence probability estimate of the event happening at 30 days, expressed as a percentage. The data values below represent the cumulative incidence probability as the percentage of participants returning to normal activities through 30 days.	30 days
Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Time to Return to Normal Activities as Reported by the Patients.	Time to return to normal activities reported by using the cumulative incidence probability estimate of the event happening at 30 days, expressed as a percentage. The data values below represent the cumulative incidence probability as the percentage of participants returning to normal activities through 30 days.	30 days
Single Arm Venous Leg Ulcer (VLU) Study: Secondary Endpoint: Time to Return to Normal Activities as Reported by the Patients.	Time to return to normal activities reported by using the cumulative incidence probability estimate of the event happening at 30 days, expressed as a percentage. The data values below represent the cumulative incidence probability as the percentage of participants returning to normal activities through 30 days.	30 days
Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Intra-procedural and Post-procedural Pain at the Index Procedure, and 7 Days and 30 Days.	Determined by using numeric rating scale (NRS) with a scale of 0-10, with '0' indicating no pain and '10' indicating worst pain imaginable.	Intra-procedure, post-procedure (on the day of the procedure immediately following treatment), 7 days and 30 days
Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Intra-procedural and Post-procedural Pain at the Index Procedure, and 7 Days and 30 Days.	Determined by using numeric rating scale (NRS) with a scale of 0-10, with '0' indicating no pain and '10' indicating worst pain imaginable.	Intra-procedure, post-procedure (on the day of the procedure immediately following treatment), 7 days and 30 days
Single Arm Venous Leg Ulcer (VLU) Study: Secondary Endpoint: Intra-procedural and Post-procedural Pain at the Index Procedure, and 7 Days and 30 Days.	Determined by using numeric rating scale (NRS) with a scale of 0-10, with '0' indicating no pain and '10' indicating worst pain imaginable.	Intra-procedure, post-procedure (on the day of the procedure immediately following treatment), 7 days and 30 days
Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Change in Venous Disease Symptoms at 7 and 30 Days, and at 6, 12, 24, 36, 48, and 60 Months Compared to Baseline.	Measured by the revised Venous Clinical Severity Score (rVCSS) and subject self-reporting. rVCSS score ranges from 0 to 30, with higher score indicating severe venous disease. The outcome measure data reports changes compared to baseline at the different time frames.	7 and 30 days, and at 6, 12 months. Data for additional time points 24, 36, 48 and 60 months will be added to additional outcome measure with next posting as data collection is still ongoing.
Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Change in Venous Disease Symptoms at 7 and 30 Days, and at 6, 12 Months Compared to Baseline.	Measured by the revised Venous Clinical Severity Score (rVCSS) and subject self-reporting. rVCSS score ranges from 0 to 30, with higher score indicating severe venous disease. The outcome measure data reports changes compared to baseline at the different time frames.	7 and 30 days, and at 6 and 12 months
Single Arm Venous Leg Ulcer (VLU) Study: Secondary Endpoint: Change in Venous Disease Symptoms at 7 and 30 Days, and at 6, 12, 24, 36, 48, and 60 Months Compared to Baseline.	Measured by the revised Venous Clinical Severity Score (rVCSS) and subject self-reporting. rVCSS score ranges from 0 to 30, with higher score indicating severe venous disease. The outcome measure data reports changes compared to baseline at the different time frames.	7 and 30 days, and at 6, 12 months. Data for additional time points 24, 36, 48 and 60 months will be added to additional outcome measure with next posting as data collection is still ongoing.
Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Change in AVVQ Score at 30 Days, and 6, 12, 24, 36, 48, and 60 Months Compared to Baseline.	The total score ranges from 0-100 points, with '0' point indicating the best quality of life and '100' points indicating worst quality of life. The outcome measure data reports changes compared to baseline at the different time frames.	30 days, and 6, 12 months. Data for additional time points 24, 36, 48 and 60 months will be added to additional outcome measure with next posting as data collection is still ongoing.
Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Change in AVVQ Score at 30 Days, and 6 and 12 Months Compared to Baseline.	The total score ranges from 0-100 points, with '0' point indicating the best quality of life and '100' points indicating worst quality of life. The outcome measure data reports changes compared to baseline at the different time frames.	30 days, and 6 and 12 months
Single Arm Venous Leg Ulcer (VLU) Study: Secondary Endpoint: Change in AVVQ Score at 30 Days, and 6, 12, 24, 36, 48, and 60 Months Compared to Baseline.	The total score ranges from 0-100 points, with '0' point indicating the best quality of life and '100' points indicating worst quality of life. The outcome measure data reports changes compared to baseline at the different time frames.	30 days, and 6, 12 months. Data for additional time points 24, 36, 48 and 60 months will be added to additional outcome measure with next posting as data collection is still ongoing.
Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Change in EuroQoL Group 5-Dimension Self-Report Questionnaire (EQ-5D-5L) at 30 Days, and 6, 12, 24, 36, 48 and 60 Months Compared to Baseline.	EQ-5D Index scale from <0 to 1.0 (<0 worse than dead, 0 is dead and 1.0 is full health). The outcome measure data reports changes compared to baseline at the different time frames.	30 days, and 6, 12 months. Data for additional time points 24, 36, 48 and 60 months will be added to additional outcome measure with next posting as data collection is still ongoing.
Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Change in EuroQoL Group 5-Dimension Self-Report Questionnaire (EQ-5D-5L) at 30 Days, and 6 and 12 Months Compared to Baseline.	EQ-5D Index scale from <0 to 1.0 (<0 worse than dead, 0 is dead and 1.0 is full health). The outcome measure data reports changes compared to baseline at the different time frames.	30 days, and 6 and 12 months
Single Arm Venous Leg Ulcer (VLU) Study: Secondary Endpoint: Change in EuroQoL Group 5-Dimension Self-Report Questionnaire (EQ-5D-5L) at 30 Days, and 6, 12, 24, 36, 48 and 60 Months Compared to Baseline.	EQ-5D Index scale from <0 to 1.0 (<0 worse than dead, 0 is dead and 1.0 is full health). The outcome measure data reports changes compared to baseline at the different time frames.	30 days, and 6, 12 months. Data for additional time points 24, 36, 48 and 60 months will be added to additional outcome measure with next posting as data collection is still ongoing.
Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Change in the 36-Item Short Form Health Survey (SF-36) Reported by the Patient at 30 Days, and 6 and 12 Months Compared to Baseline.	The total score ranges from 0 to 100, with higher scores indicating better general health perception. The outcome measure data reports changes compared to baseline at the different time frames.	30 days, and 6 and 12 months
Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Change in the 36-Item Short Form Health Survey (SF-36) Reported by the Patient at 30 Days, and 6 and 12 Months Compared to Baseline.	The total score ranges from 0 to 100, with higher scores indicating better general health perception. The outcome measure data reports changes compared to baseline at the different time frames.	30 days, and 6 and 12 months
Single Arm Venous Leg Ulcer (VLU) Study: Secondary Endpoint: Change in the 36-Item Short Form Health Survey (SF-36) Reported by the Patient at 30 Days, and 6 and 12 Months Compared to Baseline.	The total score ranges from 0 to 100, with higher scores indicating better general health perception. The outcome measure data reports changes compared to baseline at the different time frames.	30 days, and 6 and 12 months
Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12, 24, 36, 48, and 60 Months Compared to Baseline.	Subjects answer their general quality of life with potential responses on an ordinal scale: excellent, very good, good, neither good nor bad, bad, very bad, or extremely bad. Subjects also answer what their quality of life would be without varicose veins with potential responses on an ordinal scale: very much better, much better, a little better, the same, or worse. The outcome measure data reports the responses at the different time frames including baseline.	30 days, and 6, 12 months. Data for additional time points 24, 36, 48 and 60 months will be added to additional outcome measure with next posting as data collection is still ongoing.
Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12 Months Compared to Baseline.	Subjects answer their general quality of life with potential responses on an ordinal scale: excellent, very good, good, neither good nor bad, bad, very bad, or extremely bad. Subjects also answer what their quality of life would be without varicose veins with potential responses on an ordinal scale: very much better, much better, a little better, the same, or worse. The outcome measure data reports the responses at the different time frames including baseline.	30 days, and 6, 12 months
Single Arm Venous Leg Ulcer (VLU) Study: Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12, 24, 36, 48, and 60 Months Compared to Baseline.	Subjects answer their general quality of life with potential responses on an ordinal scale: excellent, very good, good, neither good nor bad, bad, very bad, or extremely bad. Subjects also answer what their quality of life would be without varicose veins with potential responses on an ordinal scale: very much better, much better, a little better, the same, or worse. The outcome measure data reports the responses at the different time frames including baseline.	30 days, and 6, 12 months. Data for additional time points 24, 36, 48 and 60 months will be added to additional outcome measure with next posting as data collection is still ongoing.
Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Provider Experience Will be Assessed Post-index Procedure, Evaluating Overall Satisfaction With the Procedure.	Measured by a 5 point Likert scale ranging from 0-5, with 5 indicating the best outcome (extremely satisfied with the treatment).	Post-index procedure, on the day of the procedure immediately following treatment
Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Provider Experience Will be Assessed Post-index Procedure, Evaluating Overall Satisfaction With the Procedure.	Measured by a 5 point Likert scale ranging from 0-5, with 5 indicating the best outcome (extremely satisfied with the treatment).	Post-index procedure, on the day of the procedure immediately following treatment
Single Arm Venous Leg Ulcer (VLU) Study: Secondary Endpoint: Provider Experience Will be Assessed Post-index Procedure, Evaluating Overall Satisfaction With the Procedure.	Measured by a 5 point Likert scale ranging from 0-5, with 5 indicating the best outcome (extremely satisfied with the treatment).	Post-index procedure, on the day of the procedure immediately following treatment
Single Arm Venous Leg Ulcer (VLU) Study: Secondary Endpoint: Peri-procedural Patient Satisfaction as Measured by a Validated Patient-centered Venous Treatment Satisfaction Questionnaire (VenousTSQe) at 30 Days.	Measured by a validated, patient-centered venous treatment satisfaction questionnaire - early (VenousTSQe). Total score ranges from 0-36, and a higher score means a higher peri-procedural venous treatment satisfaction.	30 days
Single Arm Venous Leg Ulcer (VLU) Study: Secondary Endpoint: Patient Satisfaction as Measured by a Validated Patient-centered Venous Treatment Satisfaction Questionnaire (VenousTSQs) at 30 Days.	Measured by a validated, patient-centered venous treatment satisfaction questionnaire - status (VenousTSQs). Total score ranges from 0-36, and a higher score means a higher venous treatment satisfaction.	30 days
Single Arm Venous Leg Ulcer (VLU) Study: Secondary Endpoint: Elimination of Clinically Relevant Superficial Truncal Disease in Target Vein at the Time of Index Procedure as Measured by the Percentage of Target Veins Successfully Treated.	Elimination of clinically relevant superficial truncal disease in each target vein at the time of index procedure as measured by the percentage of target vein length successfully treated.	Post-index procedure, on the day of the procedure immediately following treatment

Collaborators and Investigators

• Sponsor: Medtronic Endovascular
• Investigators: Principal Investigator: Kathleen Gibson, MD, Lake Washington Vascular, US; Principal Investigator: Manjit Gohel, MD, Addenbrooke's Hospital, UK

Study record dates

Study Major Dates

• Study Start (Actual): February 5, 2020
• Primary Completion (Actual): June 12, 2024
• Study Completion (Actual): November 10, 2025

Study Registration Dates

• First Submitted: January 8, 2019
• First Submitted That Met QC Criteria: January 25, 2019
• First Posted (Actual): January 29, 2019

Study Record Updates

• Last Update Posted (Estimated): December 30, 2025
• Last Update Submitted That Met QC Criteria: December 8, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Radiofrequency Ablation; Varicose Veins; Chronic Venous Insufficiency; Venous leg ulcer; Great Saphenous Vein; Venous reflux; VenaSeal; Endothermal Ablation; Surgical Stripping; Laser Ablation; Small Saphenous Vein; Anterior Accessory Saphenous Vein
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Skin Diseases; Skin Ulcer; Leg Ulcer; Skin and Connective Tissue Diseases; Varicose Ulcer; Varicose Veins; Therapeutics; Surgical Procedures, Operative; Ablation Techniques; Radiofrequency Therapy; Radiofrequency Ablation
• Other Study ID Numbers: MDT18034

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No