NCT05600816

SurmodiCs Pounce Venous THrOMbectomy System Post Market Clinical Follow Up Study

CHOMP: SurmodiCs Pounce Venous THrOMbectomy System Post Market Clinical Follow Up Study

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: SurModics, Inc. · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

This is an open label, prospective, non-randomised, multi-centre post market study of the POUNCE Venous Thrombectomy system for de-clotting in the peripheral vasculature (e.g., iliofemoral veins).

Detailed description

This PMCF study is designed to further evaluate the safety and performance of the POUNCE Venous Thrombectomy system in the treatment of patients with symptomatic peripheral vascular thrombus through removal of thrombus. The study will collect both qualitative and quantitative data recorded by the investigators during the procedure to further evaluate safety and performance of the device.

Conditions

• Peripheral Vascular Occlusive Disease

Interventions

Type	Name	Description
DEVICE	Pounce Venous Thrombectomy System	The device is indicated for mechanical de-clotting and controlled and selective infusion of physician specified fluids, including thrombolytics, in the peripheral vasculature.

Timeline

• Start date: 2025-04-01
• Primary completion: 2025-10-01
• Completion: 2026-10-01
• First posted: 2022-11-01
• Last updated: 2024-05-08