NCT01570101

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2011

Longer than P75 for not_applicable

Geographic Reach
4 countries

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2011

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 26, 2012

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 4, 2012

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

May 3, 2016

Status Verified

April 1, 2016

Enrollment Period

1.6 years

First QC Date

March 26, 2012

Last Update Submit

April 29, 2016

Conditions

Venous Insufficiency of Leg

Outcome Measures

Primary Outcomes (1)

  • Comparative Duplex Ultrasound

    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 Outcomes (1)

  • Safety

    Immediately post-op through 6 month Follow-up "FU"

Study Arms (1)

CE Marked Sapheon Closure System in GSV

EXPERIMENTAL

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

Device: CE Marked Sapheon Closure System

Interventions

CE Marked Sapheon Closure SystemDEVICE

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

CE Marked Sapheon Closure System in GSV

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Aareknudeklinikken

Næstved, 4700, Denmark

Location

Dermatologikum

Hamburg, 20354, Germany

Location

Klinik Proebstle

Mannheim, D - 68161, Germany

Location

Centrum Oosterawal

Alkmaar, Netherlands

Location

Countess of Chester Hospital NHS Foundation Trust

Chester, CH2 1UL, United Kingdom

Location

The Whiteley Clinic

Guildford, GU2 7RF, United Kingdom

Location

Charing Cross Hospital

London, W6 8RF, United Kingdom

Location

Related Publications (2)

  • Proebstle T, Alm J, Dimitri S, Rasmussen L, Whiteley M, Lawson J, Davies AH. Three-year follow-up results of the prospective European Multicenter Cohort Study on Cyanoacrylate Embolization for treatment of refluxing great saphenous veins. J Vasc Surg Venous Lymphat Disord. 2021 Mar;9(2):329-334. doi: 10.1016/j.jvsv.2020.05.019. Epub 2020 Jun 26.

    PMID: 32599306DERIVED

  • Proebstle TM, Alm J, Dimitri S, Rasmussen L, Whiteley M, Lawson J, Cher D, Davies A. The European multicenter cohort study on cyanoacrylate embolization of refluxing great saphenous veins. J Vasc Surg Venous Lymphat Disord. 2015 Jan;3(1):2-7. doi: 10.1016/j.jvsv.2014.09.001. Epub 2014 Oct 18.

    PMID: 26993674DERIVED

Study Officials

  • Thomas Proebstle, MD

    Klinik Proebstlé

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 26, 2012

First Posted

April 4, 2012

Study Start

December 1, 2011

Primary Completion

July 1, 2013

Study Completion

September 1, 2015

Last Updated

May 3, 2016

Record last verified: 2016-04

Data Sharing

IPD Sharing
Will not share

Locations

GB(3)DE(2)DK(1)NL(1)