European Sapheon™ Closure System Observational ProspectivE (eSCOPE) Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-12-31

Study Completion Date

2015-09-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Venous Insufficiency of Leg

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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CE Marked Sapheon Closure System in GSV

CE Marked Sapheon Closure System in closure of incompetent great saphenous veins "GSV" in a routine clinical setting.

Group Type EXPERIMENTAL

CE Marked Sapheon Closure System

Intervention Type DEVICE

CE Marked Sapheon Closure System in closure of incompetent great saphenous veins "GSV" in a routine clinical setting.

Interventions

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CE Marked Sapheon Closure System

CE Marked Sapheon Closure System in closure of incompetent great saphenous veins "GSV" in a routine clinical setting.

Intervention Type DEVICE

Eligibility Criteria

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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 C4.
* 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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No