European Sapheon™ Closure System Observational ProspectivE (eSCOPE) Study

Venous Insufficiency of Leg Clinical Trial

— eSCOPE  

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"

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01570101
• Other study ID #: CP-10763-01
• Status: Completed
• Phase: N/A
• First received: March 26, 2012
• Last updated: April 29, 2016
• Start date: December 2011
• Est. completion date: September 2015

Study information

• Verified date: April 2016
• Source: Medtronic Endovascular
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Danish National Committee on Biomedical Research EthicsGermany: Federal Institute for Drugs and Medical DevicesUnited Kingdom: National Health Service
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: September 2015
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Venous Insufficiency
• Venous Insufficiency of Leg

Intervention

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

Locations

Country	Name	City	State
Denmark	Aareknudeklinikken	Naestved
Germany	Dermatologikum	Hamburg
Germany	Klinik Proebstle	Mannheim
Netherlands	Centrum Oosterawal	Alkmaar
United Kingdom	Countess of Chester Hospital NHS Foundation Trust	Chester
United Kingdom	The Whiteley Clinic	Guildford
United Kingdom	Charing Cross Hospital	London

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Endovascular

Countries where clinical trial is conducted

Denmark,  Germany,  Netherlands,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Safety	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"	Yes