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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01570101
First Posted: April 4, 2012
Last Update Posted: May 3, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Medtronic Endovascular
  Purpose
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.

Condition Intervention
Venous Insufficiency of Leg Device: CE Marked Sapheon Closure System

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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"

Further study details as provided by Medtronic Endovascular:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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).


Enrollment: 70
Study Start Date: December 2011
Study Completion Date: September 2015
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01570101


Locations
Denmark
Aareknudeklinikken
Naestved, Denmark, 4700
Germany
Dermatologikum
Hamburg, Germany, 20354
Klinik Proebstle
Mannheim, Germany, D - 68161
Netherlands
Centrum Oosterawal
Alkmaar, Netherlands
United Kingdom
Countess of Chester Hospital NHS Foundation Trust
Chester, United Kingdom, CH2 1UL
The Whiteley Clinic
Guildford, United Kingdom, GU2 7RF
Charing Cross Hospital
London, United Kingdom, W6 8RF
Sponsors and Collaborators
Medtronic Endovascular
Investigators
Principal Investigator: Thomas Proebstle, MD Klinik Proebstlé
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Medtronic Endovascular
ClinicalTrials.gov Identifier: NCT01570101     History of Changes
Other Study ID Numbers: CP-10763-01
First Submitted: March 26, 2012
First Posted: April 4, 2012
Last Update Posted: May 3, 2016
Last Verified: April 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Venous Insufficiency
Vascular Diseases
Cardiovascular Diseases