EU Post Market Clinical Follow-Up Study of the Venclose System for Saphenous Vein Incompetence
- Conditions
- Chronic Venous Insufficiency
- Interventions
- Device: Venclose RF System
- Registration Number
- NCT04236245
- Lead Sponsor
- Venclose, Inc.
- Brief Summary
This is a prospective, non-randomized study in which patients who meet eligibility criteria and consent to participate will undergo a minimally invasive procedure using radiofrequency (RF) energy for ablation of the great saphenous vein (GSV).
- 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 After each treatment, the EVSRF™ catheter is withdrawn a single length of the heating coil and another treatment is performed, until the entire vessel has been treated.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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 25
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Venclose RF System Venclose RF System Treatment of great saphenous vein (GSV) using Venclose RF System
- Primary Outcome Measures
Name Time Method Vein Occlusion Rate 12 months Percentage of limbs with occlusion of the treated vein
Reflux-free Rate 12 months Percentage of limbs without reflux in the treated vein
- Secondary Outcome Measures
Name Time Method Clinical Etiologic Anatomic Pathophysiologic (CEAP) Classification 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)
Presence of Complications From GSV Intervention 12 months Number of limbs that presented with the listed complications and side effects resulting from the GSV intervention
Venous Clinical Severity Score (VCSS) 12 months Assessment of venous disease (Scale 0-30: MIN=0 (least severe); MAX=30 (most severe))
Trial Locations
- Locations (1)
Venenzentrum am Bruehl
🇩🇪Leipzig, Germany