Trials / Completed
CompletedNCT01570101
European Sapheon™ Closure System Observational ProspectivE (eSCOPE) Study
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"
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 70 (actual)
- Sponsor
- Medtronic Endovascular · Industry
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
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.
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | CE Marked Sapheon Closure System | CE Marked Sapheon Closure System in closure of incompetent great saphenous veins "GSV" in a routine clinical setting. |
Timeline
- Start date
- 2011-12-01
- Primary completion
- 2013-07-01
- Completion
- 2015-09-01
- First posted
- 2012-04-04
- Last updated
- 2016-05-03
Locations
7 sites across 4 countries: Denmark, Germany, Netherlands, United Kingdom
Source: ClinicalTrials.gov record NCT01570101. Inclusion in this directory is not an endorsement.