European Sapheon™ Closure System Observational ProspectivE (eSCOPE) Study
This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
First received: March 26, 2012
Last updated: November 7, 2012
Last verified: March 2012
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.
Venous Insufficiency of Leg
||Observational Model: Case-Only
Time Perspective: Prospective
||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"
Primary Outcome Measures:
Secondary Outcome Measures:
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||June 2013 (Final data collection date for primary outcome measure)
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.
|Ages Eligible for Study:
||18 Years to 70 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
Subjects presenting at primary care clinics/doctors clinics who meet the eligibility criteria will be enrolled sequentially.
- 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).
Please refer to this study by its ClinicalTrials.gov identifier: NCT01570101
|Naestved, Denmark, 4700 |
|Hamburg, Germany, 20354 |
|Mannheim, Germany, D - 68161 |
|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 |
||Thomas Proebstle, MD
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||March 26, 2012
||November 7, 2012
||Denmark: The Danish National Committee on Biomedical Research Ethics
Germany: Federal Institute for Drugs and Medical Devices
United Kingdom: National Health Service
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on June 17, 2013