Cleaner Long-tErm Assessment Registry - Venous Insights and Efficacy With eXtended Tracking (NCT07102160) | Clinical Trial Compass
RecruitingNot Applicable
Cleaner Long-tErm Assessment Registry - Venous Insights and Efficacy With eXtended Tracking
United States185 participantsStarted 2026-02-04
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. At least 18 years of age at the time of consent.
. Undergo frontline (primary) treatment with Cleaner Vac® Thrombectomy System in the peripheral venous vasculature and have at least one component introduced into the body.
. Written informed consent obtained through the IRB-approved ICF.
. Present with unilateral or bilateral lower extremity DVT involving at least one of the following veins:
. Femoral-popliteal vein
. Common femoral vein
. Iliac vein
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Technical Success
Timeframe: At the time of the index procedure
2
Composite rate of Major Adverse Events (MAEs) within 30 days post-procedure
. Contraindication to systemic or therapeutic doses of anticoagulants.
. Contraindication to iodinated contrast that cannot be adequately premedicated.
. Life expectancy less than 1 year due to advanced malignancy, as determined by the investigator at the time of enrollment
. Patients that are pregnant.
. Known coagulation disorders both acquired (Heparin Induced Thrombocytopenia, etc.) or genetic (e.g., Factor V Leiden, etc.), thrombophilia, or hypercoagulable states that, in the opinion of the Investigator, cannot be medically managed throughout the study period.
. Treatment of target venous segment with thrombolytics within previous 14 days of the index procedure.
. Known congenital anatomic anomalies of the inferior vena cava (IVC) or iliac veins.