European Sapheon™ Closure System Observational ProspectivE (eSCOPE) Study (eSCOPE)

April 29, 2016 updated by: Medtronic Endovascular

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"

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Naestved, Denmark, 4700
        • Aareknudeklinikken
  • Germany
      • Hamburg, Germany, 20354
        • Dermatologikum
      • Mannheim, Germany, D - 68161
        • Klinik Proebstle
  • Netherlands
      • Alkmaar, Netherlands
        • Centrum Oosterawal
  • United Kingdom
      • Chester, United Kingdom, CH2 1UL
        • Countess Of Chester Hospital NHS Foundation Trust
      • Guildford, United Kingdom, GU2 7RF
        • The Whiteley Clinic
      • London, United Kingdom, W6 8RF
        • Charing Cross Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Immediately Post-procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety
Time Frame: Immediately post-op through 6 month Follow-up "FU"
The Secondary endpoint is safety, reflected by the rate of occurrence of all adverse events (procedure and non-procedure related; serious and non-serious).
Immediately post-op through 6 month Follow-up "FU"

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medtronic Endovascular

Investigators

  • Principal Investigator: Thomas Proebstle, MD, Klinik Proebstle

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2011

Primary Completion (Actual)

July 1, 2013

Study Completion (Actual)

September 1, 2015

Study Registration Dates

First Submitted

March 26, 2012

First Submitted That Met QC Criteria

March 30, 2012

First Posted (Estimate)

April 4, 2012

Study Record Updates

Last Update Posted (Estimate)

May 3, 2016

Last Update Submitted That Met QC Criteria

April 29, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CP-10763-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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.

Clinical Trials on Venous Insufficiency of Leg

Clinical Trials on CE Marked Sapheon Closure System

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Burundi

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe