- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04236245
EU Post Market Clinical Follow-Up Study of the Venclose System for Saphenous Vein Incompetence
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Subjects who meet eligibility criteria will undergo a procedure using the Venclose Radiofrequency (RF) System to treat the great saphenous vein.
The technique involves percutaneous access and insertion of the endovenous sectional radiofrequency (EVSRF™) catheter into the target vein under ultrasound guidance and relies on the use of local anesthesia and thermal energy, from a radiofrequency generator, applied to the target vein. After each treatment, the EVSRF™ catheter is withdrawn a single length of the heating coil and another treatment is performed, until the entire vessel has been treated.
After the treatment procedure, subjects will be evaluated four (4) times to assess vein recanalization and reflux, and to determine the incidence of adverse events.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Leipzig, Germany, 04109
- Venenzentrum am Bruehl
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Subject is male or female and 18 to 80 years old (inclusive) at time of enrollment (signing of consent).
- Subject has significant venous reflux by Duplex Ultrasound (DUS), defined as reverse flow with reflux duration greater than 0.5 seconds after the Valsalva maneuver or distal augmentation while the patient is standing or in reverse Trendelenburg position.
- Subject is eligible for endovascular treatment, as determined by the treating investigator.
- Subject's general physical condition allows for a significant amount of ambulation after the procedure, as determined by the treating investigator.
- Subject is willing and able to complete study requirements, including all follow-up visits and assessments.
- Subject voluntarily provides written informed consent to participate in this study.
Exclusion Criteria:
- There is evidence of old or fresh thrombus in the subject's diseased vein segment to be treated, as determined by Duplex Ultrasound (DUS) within 2 weeks prior to the index procedure.
- In the judgment of the treating investigator heat energy delivery to the subject would be contraindicated.
- Subject is concurrently participating in another interventional clinical trial.
- Subject is pregnant or plans to be pregnant or lactating at the time of the treatment procedure.
- Subject has known or suspected allergies or contraindications to any general or local anesthetic agents and/or any antibiotic medication that cannot be adequately pre-treated.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Venclose RF System
Treatment of great saphenous vein (GSV) using Venclose RF System
|
Treatment of great saphenous vein (GSV) using Venclose RF System
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Vein Occlusion Rate
Time Frame: 3 days
|
Percentage of limbs with occlusion of the treated vein
|
3 days
|
Vein Occlusion Rate
Time Frame: 3 months
|
Percentage of limbs with occlusion of the treated vein
|
3 months
|
Vein Occlusion Rate
Time Frame: 6 months
|
Percentage of limbs with occlusion of the treated vein
|
6 months
|
Vein Occlusion Rate
Time Frame: 12 months
|
Percentage of limbs with occlusion of the treated vein
|
12 months
|
Reflux-free Rate
Time Frame: 3 days
|
Percentage of limbs without reflux in the treated vein
|
3 days
|
Reflux-free Rate
Time Frame: 3 months
|
Percentage of limbs without reflux in the treated vein
|
3 months
|
Reflux-free Rate
Time Frame: 6 months
|
Percentage of limbs without reflux in the treated vein
|
6 months
|
Reflux-free Rate
Time Frame: 12 months
|
Percentage of limbs without reflux in the treated vein
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clinical Etiologic Anatomic Pathophysiologic (CEAP) Classification
Time Frame: Baseline
|
Clinical signs and symptoms of lower limb venous disease (Scale C0-C6: MIN: C0=no visible or palpable signs of venous disease; MAX: C6=active venous ulcer)
|
Baseline
|
Clinical Etiologic Anatomic Pathophysiologic (CEAP) Classification
Time Frame: 3 days
|
Clinical signs and symptoms of lower limb venous disease (Scale C0-C6: MIN: C0=no visible or palpable signs of venous disease; MAX: C6=active venous ulcer)
|
3 days
|
Clinical Etiologic Anatomic Pathophysiologic (CEAP) Classification
Time Frame: 3 months
|
Clinical signs and symptoms of lower limb venous disease (Scale C0-C6: MIN: C0=no visible or palpable signs of venous disease; MAX: C6=active venous ulcer
|
3 months
|
Clinical Etiologic Anatomic Pathophysiologic (CEAP) Classification
Time Frame: 6 months
|
Clinical signs and symptoms of lower limb venous disease (Scale C0-C6: MIN: C0=no visible or palpable signs of venous disease; MAX: C6=active venous ulcer)
|
6 months
|
Clinical Etiologic Anatomic Pathophysiologic (CEAP) Classification
Time Frame: 12 months
|
Clinical signs and symptoms of lower limb venous disease (Scale C0-C6: MIN: C0=no visible or palpable signs of venous disease; MAX: C6=active venous ulcer)
|
12 months
|
Venous Clinical Severity Score (VCSS)
Time Frame: Baseline
|
Assessment of venous disease (Scale 0-30: MIN=0 (least severe); MAX=30 (most severe))
|
Baseline
|
Venous Clinical Severity Score (VCSS)
Time Frame: 3 days
|
Assessment of venous disease (Scale 0-30: MIN=0 (least severe); MAX=30 (most severe))
|
3 days
|
Venous Clinical Severity Score (VCSS)
Time Frame: 3 months
|
Assessment of venous disease (Scale 0-30: MIN=0 (least severe); MAX=30 (most severe))
|
3 months
|
Venous Clinical Severity Score (VCSS)
Time Frame: 6 months
|
Assessment of venous disease (Scale 0-30: MIN=0 (least severe); MAX=30 (most severe))
|
6 months
|
Venous Clinical Severity Score (VCSS)
Time Frame: 12 months
|
Assessment of venous disease (Scale 0-30: MIN=0 (least severe); MAX=30 (most severe))
|
12 months
|
Presence of Complications From GSV Intervention
Time Frame: up to 3 days
|
Number of limbs that presented with the listed complications and side effects resulting from the GSV intervention
|
up to 3 days
|
Presence of Complications From GSV Intervention
Time Frame: 3 months
|
Number of limbs that presented with the listed complications and side effects resulting from the GSV intervention
|
3 months
|
Presence of Complications From GSV Intervention
Time Frame: 6 months
|
Number of limbs that presented with the listed complications and side effects resulting from the GSV intervention
|
6 months
|
Presence of Complications From GSV Intervention
Time Frame: 12 months
|
Number of limbs that presented with the listed complications and side effects resulting from the GSV intervention
|
12 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Thomas Mattausch, Dr. med, Venenzentrum am Bruehl
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- VENC17A
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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