Cleaner Long-tErm Assessment Registry - Venous Insights and Efficacy With eXtended Tracking

Part of paid clinical trials in Tampa, Florida.

Sponsor
Argon Medical Devices
Study ID
NCT07102160
Status
Recruiting
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Conditions

  • Deep Vein Thrombosis (DVT)
  • Thrombus in the Central and Peripheral Circulatory System, Including Saphenous Vein Grafts
  • Thrombus in the Peripheral Venous Vasculature
  • Venous Embolism

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Aspiration thrombectomy system — DEVICE
    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.

Study Details

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.

Key Dates

Start date
Feb 4, 2026
Status verified
Apr 2026
Primary completion
Jun 30, 2029
Completion
Jun 30, 2029

Study Design

Enrollment
185 participants (estimated)

Arms

  • Arm: DVT Subgroup
    This is a defined cohort focused on patients with lower extremity proximal deep vein thrombosis (DVT) who will undergo treatment with Cleaner Vac® Thrombectomy System. Participants will complete required follow-up at discharge and at 1, 6, 12, and 24 months.

Primary Outcome Measure

Technical Success [ Time Frame: At the time of the index procedure ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Baycare Health SystemTampaFlorida33607
Kristin Grey, BS
[email protected]
410-736-2732
Rachel Widener, BAS, R.T.(T)(ARRT)
[email protected]
727-820-6940
Ankit Pansara, MD (PRINCIPAL_INVESTIGATOR)
St. Elizabeth Healthcare - EdgewoodEdgewoodKentucky41017
Colleen Bill, RN, BSN, CPHQ
[email protected]
(859) 301-5473
Alisha Hartmann
[email protected]
Alexander H Hou, MD (PRINCIPAL_INVESTIGATOR)
Baylor Scott & White The Heart Hospital - PlanoPlanoTexas75093
Erika V Ortiz, BA
[email protected]
469-814-4977
Osniel V Ramos
[email protected]
469-814-4862
Mazin Foteh, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Tampa, FL

By research site
Baycare Health System· Tampa, FLSt. Elizabeth Healthcare - Edgewood· Edgewood, KYBaylor Scott & White The Heart Hospital - Plano· Plano, TX

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