CompletedNot Applicable

The Closer Trial: A Safety and Efficacy Study of the Rex Medical Vascular Sealing System

United States220 participantsStarted 2014-05

Plain-language summary

The objective of this trial is to demonstrate the safety and effectiveness of the Rex Medical Closer Vascular Sealing System in sealing femoral arterial access sites.

Who can participate

Age range

18 Years – 80 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.

Exclusion criteria

. \- Significant bleeding diatheses or coagulopathy
. \- Planned endovascular or surgical procedures within next 30 days
. \- Planned ipsilateral femoral arteriotomy within next 90 days
. \- Arteriotomy in ipsilateral groin within the past 30 days with any residual hematoma, significant bruising or vascular complication
. \- Previous vessel closure device used in ipsilateral groin within the past 90 days
. \- Previous vascular surgery or repair in the vicinity of the target access site
. \- Severe peripheral vascular disease in the ipsilateral limb requiring surgical or endovascular treatment within the pervious 30 days or next 30 days
. \- Existing nerve damage in ipsilateral limb

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

Time to Hemostasis

Timeframe: procedural, usually within 15 minutes of enrollment

Rate of Combined Major Access Site Closure-related Complications

Timeframe: Through 30 days +/- 7 days

Trial details

NCT IDNCT02136004

SponsorRex Medical

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2015-02

Results submitted2016-11-01

View on ClinicalTrials.gov More Surgical Wound trials