SurmodiCs Pounce Venous THrOMbectomy System Post Market Clinical Follow Up Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-01

Study Completion Date

2026-10-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Safety, Tolerability and Performance of the NucleoCapture Device in the Reduction of Circulating CfDNA/NETs in Subjects with Sepsis

NCT05647096

Sepsis Respiratory Failure

NOT_YET_RECRUITING NA

Survey of Tourniquet Use in a Combat Support Hospital

NCT00517166

Vascular Injury

COMPLETED

Study to Demonstrate the Efficacy and Safety of Convatec ConvaFoam™ Silicone, ConvaFoam™ Border and ConvaFoam™ Non-adhesive Dressings to Protect Against Skin Breakdown

NCT05902182

Skin Breakdown

UNKNOWN NA

An Evaluation of the PureWick™ Male External Catheter Versus an Established Comparator Overnight in the Home Setting for Incontinence in Adult Males

NCT07282860

Urinary Incontinence

ENROLLING_BY_INVITATION NA

Prospective, Multi-center, Single-arm Study to Assess the Safety of Retrieval of the Recovery G2 Filter.

NCT00556426

Pulmonary Embolism Venous Thromboembolic Disease

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Peripheral Vascular Occlusive Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Pounce Venous Thrombectomy System

Subjects admitted for endovascular thrombus removal using the Pounce Venous Thrombectomy System

Group Type OTHER

Pounce Venous Thrombectomy System

Intervention Type DEVICE

The device is indicated for mechanical de-clotting and controlled and selective infusion of physician specified fluids, including thrombolytics, in the peripheral vasculature.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Individuals aged 18 years or older
2. Patients with peripheral vascular thrombus (e.g., iliofemoral) as confirmed by Doppler Ultrasonography (DUS)
3. Voluntary informed written consent, given before performance of any clinical investigation-related procedure not part of standard medical care, and with the understanding that consent may be withdrawn at any time without prejudice to future medical care
4. Patients who would likely experience benefit from mechanical thrombus removal

Exclusion Criteria

1. Presence of a stent in the target vein
2. Known aggressive hypercoagulable states such as antiphospholipid antibody syndrome, Protein C/S Deficiency, Antithrombin deficiency, homozygous prothrombin gene mutation or homozygous Factor V Leiden
3. Limb-threatening circulatory compromise
4. Known symptomatic Pulmonary Embolism at the time of enrollment with or without severe RV dysfunction
5. Patients with a positive COVID test result at the time of the procedure
6. Patients who, according to the investigator, have a venous thrombus that may be associated with a prior COVID infection
7. History of, or active heparin induced thrombocytopenia (HIT)
8. Inability to withstand endovascular procedures
9. Life expectancy \< 1 year
10. Participation in any other drug or device studies that have not reached the primary endpoint follow up, which could compromise the results of either trial
11. Patient has any concurrent condition that, in the Investigator's opinion, would jeopardize the safety of the subject or compliance with the protocol
12. Likely inability to comply with the protocol or cooperate fully with the investigator and site personnel
13. Known or suspected abuse of alcohol, narcotics or non-prescription drugs that would jeopardize study outcomes in the Investigator's opinion
14. Inability to provide informed consent or to comply with study assessments (e.g., due to cognitive impairment or geographic distance)

Eligible Sex

ALL

Accepts Healthy Volunteers

No