Post Market Study - "European Observational Study of the Sapheon™ Closure System for the Definitive Treatment of Incompetent Great Saphenous Veins: A Prospective Single Arm Multicenter Clinical Observational Study"
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 70
- Locations
- 13
- Primary Endpoint
- Comparative Duplex Ultrasound
Study Overview
Brief Summary
The primary objective for this clinical study is to assess the role of the CE Marked Sapheon Closure System in closure of incompetent great saphenous veins "GSV" in a routine clinical setting.
Detailed Description
This is a post market, observational study of closure of the great saphenous vein "GSV". Efficacy and safety (adverse events) will be compared to appropriate literature reports to determine if the results of the treatment of reflux disease with the Sapheon Closure System are consistent with or better than the expectations of the medical community for alternative treatments, specifically Laser Thermal Ablation and Radiofrequency Ablation. Additional comparison points may include measurements of pain and/or length of time to return to work.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age ≥18 years and ≤ 70 years of age.
- •Symptomatic primary Great Saphenous Vein "GSV" incompetence diagnosed by clinical symptoms, with or without visible varicosities, and confirmed by duplex ultrasound imaging.
- •CEAP classification of C2, C3 or C
- •Ability to walk unassisted.
- •Ability to attend follow-up visits.
- •Ability to understand the requirements of the study and to provide written informed consent.
- •"GSV" on standing pre-procedure Doppler Ultrasound ≥3mm and ≤10mm (maximum diameter).
Exclusion Criteria
- •Life expectancy < 1 year.
- •Regular pain medication.
- •Anticoagulation including Heparin or Coumadin.
- •Previous Deep Vein Thrombosis "DVT".
- •Previous superficial thrombophlebitis in "GSV".
- •Previous venous treatment on target limb.
- •Known Hyper-coagulable disorder.
- •Conditions which prevent routine vein treatment like:
- •Acute disease,
- •Immobilization or inability to ambulate, and
- •Pregnancy.
- •Tortuous "GSV", which in the opinion of the Investigator will limit catheter placement. (no 2 primary access sites allowed).
- •Incompetent ipsilateral small saphenous or anterior accessory great saphenous vein.
- •Known sensitivity to the cyanoacrylate "CA" adhesive.
- •Current participation in another clinical study involving an investigational agent or treatment, or within the 30 days prior to enrollment.
Outcomes
Primary Outcomes
Comparative Duplex Ultrasound
Time Frame: Immediately Post-procedure
The Primary endpoint is a change in duplex ultrasound immediately post-procedure as compared to the pre-procedure duplex ultrasound, proving great saphenous vein closure with lack of pathological reflux.
Secondary Outcomes
- Safety(Immediately post-op through 6 month Follow-up "FU")