Trials / Recruiting
RecruitingNCT07102160
Cleaner Long-tErm Assessment Registry - Venous Insights and Efficacy With eXtended Tracking
A Prospective, Multi-Center, Open-Label Clinical Investigation of the Cleaner Vac® Thrombectomy System for Treatment of Lower Extremity Proximal Deep Vein Thrombosis (DVT)
- Status
- Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 185 (estimated)
- Sponsor
- Argon Medical Devices · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The primary objective of this clinical investigation is to evaluate the safety and effectiveness of the Cleaner Vac® Thrombectomy System for the treatment of thrombus in patients with lower extremity proximal deep vein thrombosis (DVT). This prospective, multi-center, open-label study will assess clinical outcomes, device performance, and procedural success in a single DVT study cohort.
Conditions
- Deep Vein Thrombosis (DVT)
- Thrombus in the Peripheral Venous Vasculature
- Venous Embolism
- Thrombus in the Central and Peripheral Circulatory System, Including Saphenous Vein Grafts
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Aspiration thrombectomy system | The Cleaner Vac® Thrombectomy System is a percutaneous mechanical aspiration thrombectomy device designed for the removal of fresh, soft thrombi and emboli from the peripheral venous vasculature. The system includes an aspiration canister with integrated pump, an 18F aspiration catheter, a handpiece with aspiration control lever, a dilator, and an optional flushing adapter. The device operates via controlled suction to extract thrombus and restore venous patency. |
Timeline
- Start date
- 2026-02-04
- Primary completion
- 2029-06-01
- Completion
- 2029-06-01
- First posted
- 2025-08-03
- Last updated
- 2026-02-20
Locations
3 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT07102160. Inclusion in this directory is not an endorsement.