ClosureFAST vs. Laser Ablation for the Treatment of GSV Disease: A Multicenter, Single-Blinded, Randomized Study. (RECOVERY)

Radiofrequency Endovenous ClosureFAST vs. Laser Ablation for the Treatment of Great Saphenous Reflux: A Multicenter, Single-Blinded, Randomized Study (RECOVERY)

The objective of this post-market study is to compare the post-procedure recovery between two types of minimally invasive catheter treatments for venous disease in the Great Saphenous Vein.

Study Overview

• Status: Completed
• Conditions: Venous Reflux
• Intervention / Treatment: Device: Seg. RF Ablation & ClosureFAST catheter; Device: Endovenous Laser

Detailed Description

Comparison of the post-procedure recovery of radiofrequency (RFA) treatment vs. laser treatment.

• Study Type: Interventional
• Enrollment (Actual): 69
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Oregon
    • Portland, Oregon, United States, 97239
      • Oregon Health Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• All subjects must provide written informed consent.
• Must be a candidate for either treatment with Radiofrequency Ablation (RFA) or endovenous laser.

Exclusion Criteria:

• Subjects who require additional treatments in either leg within 30 days before or after the study procedure.
• Subjects who are participating in another investigational study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Seg. RF Ablation & ClosureFAST catheter	Device: Seg. RF Ablation & ClosureFAST catheter; Seg. RF Ablation & ClosureFAST catheter; Other Names: VNUS
Active Comparator: Endovenous Laser; Treatment invention of venous disease with an Endovenous Laser.	Device: Endovenous Laser; laser catheter; Other Names: Commercially approved laser catheter systems.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain	Pain 0-10 scale (10 most severe)	48 Hour
Pain	Pain 0-10 scale (10 most severe)	1 Week
Pain	Pain 0-10 scale (10 most severe)	2 Weeks
Pain	Pain 0-10 scale (10 most severe)	1 Month
Tenderness	Tenderness 0-10 scale (10 most severe)	48 Hour
Tenderness	Tenderness 0-10 scale (10 most severe)	1 Week
Tenderness	Tenderness 0-10 scale (10 most severe)	2 Weeks
Tenderness	Tenderness 0-10 scale (10 most severe)	1 Month
Ecchymosis	0-5 scale (5 most severe) 0: None; <25%; 25-50%; 50-75%; 75-100%; Above or below treated (tx) segment	48 Hours post treatment (no baseline)
Ecchymosis	0-5 scale (5 most severe) 0: None; <25%; 25-50%; 50-75%; 75-100%; Above or below tx segment	1 Week post treatment (no baseline)
Ecchymosis	0-5 scale (5 most severe) 0: None; <25%; 25-50%; 50-75%; 75-100%; Above or below tx segment	2 Weeks post treatment (no baseline)
Ecchymosis	0-5 scale (5 most severe) 0: None; <25%; 25-50%; 50-75%; 75-100%; Above or below tx segment	1 Month post treatment (no baseline)
Complications	Sequelae at any follow-up	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
VCSS	Venous Clinical Severity Score (0-30 total overall score): 0(minimum)- No evidence of venous disease 30(maximum)- Severe venous disease	48 Hours
VCSS	Venous Clinical Severity Score (0-30 total overall score): 0(minimum)- No evidence of venous disease 30(maximum)- Severe venous disease	1 Week
VCSS	Venous Clinical Severity Score (0-30 total overall score): 0(minimum)- No evidence of venous disease 30(maximum)- Severe venous disease	2 Weeks
VCSS	Venous Clinical Severity Score (0-30 total overall score): 0(minimum)- No evidence of venous disease 30(maximum)- Severe venous disease	1 Month
Change in CIVIQ QOL	Chronic Venous Insufficiency Questionnaire(CIVIQ) for Quality of Life(QOL). (Min 20- Max 100). Global index and an outline of 4 quality-of-life dimensions: "pain" (4 items), "physical" (4 items), "psychological" (9 items), and "social" (3 items). A low global (total) score corresponds to greater patient comfort. Change from Baseline	48 Hours
Change in CIVIQ QOL	Chronic Venous Insufficiency Questionnaire(CIVIQ) for Quality of Life(QOL). (Min 20- Max 100). Global index and an outline of 4 quality-of-life dimensions: "pain" (4 items), "physical" (4 items), "psychological" (9 items), and "social" (3 items). A low global (total) score corresponds to greater patient comfort. Change from Baseline	1 Week
Change in CIVIQ QOL	Chronic Venous Insufficiency Questionnaire(CIVIQ) for Quality of Life(QOL) (Min 20- Max 100). Global index and an outline of 4 quality-of-life dimensions: "pain" (4 items), "physical" (4 items), "psychological" (9 items), and "social" (3 items). A low global (total) score corresponds to greater patient comfort. Change from Baseline	2 Week
Change in CIVIQ QOL	Chronic Venous Insufficiency Questionnaire(CIVIQ) for Quality of Life(QOL). (Min 20- Max 100). Global index and an outline of 4 quality-of-life dimensions: "pain" (4 items), "physical" (4 items), "psychological" (9 items), and "social" (3 items). A low global (total) score corresponds to greater patient comfort. Change from Baseline	1 Month

Collaborators and Investigators

• Sponsor: Medtronic Endovascular
• Collaborators: VNUS Medical Technologies, A Covidien Company
• Investigators: Study Director: Lian Cunningham, MD, VNUS Medical Technologies, A Covidien Company

Publications and helpful links

General Publications

• Almeida JI, Kaufman J, Gockeritz O, Chopra P, Evans MT, Hoheim DF, Makhoul RG, Richards T, Wenzel C, Raines JK. Radiofrequency endovenous ClosureFAST versus laser ablation for the treatment of great saphenous reflux: a multicenter, single-blinded, randomized study (RECOVERY study). J Vasc Interv Radiol. 2009 Jun;20(6):752-9. doi: 10.1016/j.jvir.2009.03.008. Epub 2009 Apr 22.

Study record dates

Study Major Dates

• Study Start: March 1, 2007
• Primary Completion (Actual): January 1, 2008
• Study Completion (Actual): January 1, 2008

Study Registration Dates

• First Submitted: July 27, 2007
• First Submitted That Met QC Criteria: July 27, 2007
• First Posted (Estimate): July 31, 2007

Study Record Updates

• Last Update Posted (Actual): July 12, 2017
• Last Update Submitted That Met QC Criteria: June 13, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Keywords: Varicose veins, venous reflux, GSV disease
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastroesophageal Reflux
• Other Study ID Numbers: CVL-06-03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes