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NCT01807585 · ClinicalTrials.gov registry record · NA
VenaSeal Sapheon Closure System Pivotal Study (VeClose)
A NA study of Great Saphenous Vein (GSV) With Venous Reflux Disease, sponsored by Medtronic Endovascular.
- Completed
- Registry status
- NA
- Development phase
- 242
- Enrollment target
- 10
- Study locations
NCT01807585: Completed NA study of Great Saphenous Vein (GSV) With Venous Reflux Disease, sponsored by Medtronic Endovascular.
NCT01807585 is a NA study of Great Saphenous Vein (GSV) With Venous Reflux Disease that has completed, run by Medtronic Endovascular. The registered enrollment target is 242 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (83% lower). The trial reports 10 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01807585, a NA study of Great Saphenous Vein (GSV) With Venous Reflux Disease, has completed, sponsored by Medtronic Endovascular.
- COMPLETED
- Registry status
- NA
- Development phase
- 242 participants
- Enrollment target
- 10
- Study locations
Study Summary
The VeClose pivotal study was a controlled, randomized, prospective, multicenter, pivotal study in which patients with venous reflux in the great saphenous vein (GSV) were treated with either the VenaSeal closure system (VenaSeal SCS) or radiofrequency ablation (RFA) therapy.
Primary Outcome
The primary endpoint of the study was complete closure of the target vein at 3 months after index treatment as judged by the vascular ultrasound laboratory. Complete closure was defined as Doppler ultrasound examination showing closure along the entire treated vein segment with no discrete segments of patency exceeding 5 cm.
Conditions Studied
Interventions
- DEVICE VenaSeal SCS
- DEVICE ClosureFast Radiofrequency Ablation (RFA)
- DEVICE Roll-in (VenaSeal SCS)
Study Locations (10)
Illinois
- Vein Clinics of America - Oakbrook Terrace
- Prairie Education & Research Cooperative - Springfield
Arizona
- Morrison Vein Institute - Scottsdale
California
- GBK Cosmetic Laser Dermatology - San Diego
Colorado
- Radiology Imaging Associates (RIA) - Greenwood Village
Maryland
- MD Laser Skin & Vein Institute - Hunt Valley
New York
- Vein Institute of Buffalo - North Tonawanda
Oregon
- Inovia Vein Specialty Center - Bend
Virginia
- Sentara Vascular Specialist - Virginia Beach
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 242 participants |
| Start Date | 2013-03 |
| Est. Completion | 2017-04-10 |
| Phase | NA |
What the finished NCT01807585 record still lists
NCT01807585 is an interventional study that assigns participants to a tested intervention. The registered 242 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (83% lower).
The record links to 1 condition, with Great Saphenous Vein (GSV) With Venous Reflux Disease appearing as the primary indexed condition, and to 3 interventions - of which VenaSeal SCS is the first listed.
NCT01807585 lists 10 locations in 9 states (Illinois, Arizona, California).
Frequently Asked Questions
What is clinical trial NCT01807585 about?
NCT01807585 is a clinical study titled "VenaSeal Sapheon Closure System Pivotal Study (VeClose)". The VeClose pivotal study was a controlled, randomized, prospective, multicenter, pivotal study in which patients with venous reflux in the great saphenous vein (GSV) were treated with either the VenaSeal closure system (VenaSeal SCS) or radiofrequency ablation (RFA) therapy.
What is the current status of trial NCT01807585?
This trial is currently completed. It is a NA study. The enrollment target is 242 participants. The study started on 2013-03. Estimated completion is 2017-04-10.
What conditions does trial NCT01807585 study?
This clinical trial studies the following conditions: Great Saphenous Vein (GSV) With Venous Reflux Disease.
What interventions are being tested in trial NCT01807585?
The interventions under investigation include: VenaSeal SCS (DEVICE), ClosureFast Radiofrequency Ablation (RFA) (DEVICE), Roll-in (VenaSeal SCS) (DEVICE).
Who is sponsoring clinical trial NCT01807585?
This trial is sponsored by Medtronic Endovascular, which has 25 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01807585 being conducted?
This trial has 10 study locations across Arizona, California, Colorado, Illinois, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01807585's enrollment target sits among peer trials
242 439th of 2000 higher than 1,561 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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