Trials / Terminated
TerminatedNCT03820947
VenaSeal Spectrum: Global Post-Market Randomized Controlled Trial
Global, Post-Market, Prospective, Multi-Center, Randomized Controlled Trial of the VenaSeal™ Closure System vs. Surgical Stripping or Endothermal Ablation (ETA) for the Treatment of Early & Advanced Stage Superficial Venous Disease
- Status
- Terminated
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 506 (actual)
- Sponsor
- Medtronic Endovascular · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Global, Post-Market, Prospective, Multi-Center, Randomized Controlled Trial of the VenaSeal™ Closure System vs. Surgical Stripping or Endothermal Ablation (ETA) for the Treatment of Early and Advanced Stage Superficial Venous Disease
Detailed description
The study is designed with two randomized studies and one single arm study. Two randomized studies are for CEAP 2-5 subjects: 1. VenaSeal vs. Surgical Stripping Study (outside of the United States only) 2. VenaSeal vs. ETA Study The single arm study is for CEAP 6 subjects with active venous leg ulcers (VLU): 1\. VLU Study
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | VenaSeal™ System | The VenaSeal™ System is the non-tumescent, non-thermal, non-sclerosant device that uses a proprietary medical adhesive delivered endovenously to close the vein. |
| DEVICE | Endothermal Ablation (ETA) | ETA includes EVLA that uses laser or RFA that uses radiofrequency heating to close the vein. Heat is applied in both EVLA and RFA therapies to close the vein. Subject can be treated with either EVLA or RFA if randomized to ETA arm per site's standard practice. |
| PROCEDURE | Surgical Stripping | Surgical stripping involves stripping (removal) of the diseased vein via surgical procedures. |
Timeline
- Start date
- 2020-02-05
- Primary completion
- 2024-06-12
- Completion
- 2025-11-10
- First posted
- 2019-01-29
- Last updated
- 2025-12-30
- Results posted
- 2025-09-04
Locations
32 sites across 10 countries: United States, Australia, Canada, France, Germany, Italy, Netherlands, South Korea, Spain, United Kingdom
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03820947. Inclusion in this directory is not an endorsement.