CompletedPhase 4

The Safety and Efficacy of an Extravascular, Water-Soluble Sealant for Venous Access-Site Closure

United States208 participantsStarted 2015-06

Plain-language summary

Evaluate the safety of the MynxGrip™ extravascular sealant for common femoral vein closure following both diagnostic and interventional procedures as assessed by clinical and imaging criteria.

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.

Exclusion criteria

. Patient has a history of a bleeding disorder
. Previous history of venous thrombosis or thromboembolism
. Patient is pregnant or lactating
. Patient has a known severe allergy to contrast medium
. Patient has a known allergy to PEG

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

Assessment of Venous Thrombosis

Timeframe: Subjects will be followed up until their discharge from the hospital, and expected average of 24 hours

Bleeding or Vascular Related Complications

Timeframe: Subjects will be followed up until their discharge from the hospital, and expected average of 24 hours

Device/Procedure Failure

Timeframe: intraoperative

Trial details

NCT IDNCT02438475

SponsorMedstar Health Research Institute

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2017-08

Results submitted2020-10-23

View on ClinicalTrials.gov More Cardiac Diagnostic Procedure trials

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.

Exclusion criteria

. Patient has a history of a bleeding disorder
. Previous history of venous thrombosis or thromboembolism
. Patient is pregnant or lactating
. Patient has a known severe allergy to contrast medium
. Patient has a known allergy to PEG

What they're measuring

Assessment of Venous Thrombosis

Timeframe: Subjects will be followed up until their discharge from the hospital, and expected average of 24 hours

Bleeding or Vascular Related Complications

Timeframe: Subjects will be followed up until their discharge from the hospital, and expected average of 24 hours

Device/Procedure Failure

Timeframe: intraoperative