European Sapheon™ Closure System Observational ProspectivE (eSCOPE) Study
This study is ongoing, but not recruiting participants.
Sponsor:
Sapheon, Inc.
Information provided by (Responsible Party):
Sapheon, Inc.
ClinicalTrials.gov Identifier:
NCT01570101
First received: March 26, 2012
Last updated: November 7, 2012
Last verified: March 2012
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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 |
|---|
|
Venous Insufficiency of Leg |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Prospective |
| 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 Sapheon, Inc.:
Primary Outcome Measures:
- Comparative Duplex Ultrasound [ Time Frame: Immediately Post-procedure ] [ Designated as safety issue: No ]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" ] [ Designated as safety issue: Yes ]The Secondary endpoint is safety, reflected by the rate of occurrence of all adverse events (procedure and non-procedure related; serious and non-serious).
| Estimated Enrollment: | 80 |
| Study Start Date: | December 2011 |
| Estimated Study Completion Date: | June 2015 |
| 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.
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Study Population
Subjects presenting at primary care clinics/doctors clinics who meet the eligibility criteria will be enrolled sequentially.
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01570101
Locations
| Denmark | |
| Aareknudeklinikken | |
| Naestved, Denmark, 4700 | |
| Germany | |
| Dermatologikum | |
| Hamburg, Germany, 20354 | |
| Klinik Proebstle | |
| Mannheim, Germany, D - 68161 | |
| 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
Sapheon, Inc.
Investigators
| Principal Investigator: | Thomas Proebstle, MD | Klinik Proebstlé |
More Information
No publications provided
| Responsible Party: | Sapheon, Inc. |
| ClinicalTrials.gov Identifier: | NCT01570101 History of Changes |
| Other Study ID Numbers: | CP-10763-01 |
| Study First Received: | March 26, 2012 |
| Last Updated: | November 7, 2012 |
| Health Authority: | 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:
|
Venous Insufficiency Vascular Diseases Cardiovascular Diseases |
ClinicalTrials.gov processed this record on June 17, 2013