Trials / Completed
CompletedNCT04386785
Venclose RF Ablation System for the Treatment of IPVs
Investigator Initiated Safety Study Using the Venclose Vestico (Commercial Name TBD) Radiofrequency (RF) Ablation System for the Treatment of Incompetent Perforator Veins (IPVs)
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 27 (actual)
- Sponsor
- Venclose, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
A feasibility study conducted in patients with incompetent (i.e. refluxing) perforator veins were treated using the Venclose RF Ablation System.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Radiofrequency (RF) Thermal Ablation of Incompetent Perforator Veins | The physician operator will access the IPV and advance the device to the target treatment position using ultrasound guidance. After providing local anesthesia to the vein and surrounding tissues, thermal ablation energy is delivered to the vein wall. After treatment is complete, the device is removed and vessel closure confirmed with duplex ultrasound. |
Timeline
- Start date
- 2020-05-23
- Primary completion
- 2021-04-13
- Completion
- 2021-05-13
- First posted
- 2020-05-13
- Last updated
- 2022-05-27
- Results posted
- 2022-05-27
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04386785. Inclusion in this directory is not an endorsement.