SECURE Post-Market Study (NCT07756489) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
SECURE Post-Market Study
65 participantsStarted 2026-10
Plain-language summary
The purpose of this post-market study is to generate post-market, real- world evidence on the safety and performance of COAPTIUM® CONNECT with TISSIUM® LIGHT for the atraumatic sutureless repair of acute digital (sensory) injuries of the hand in adults through prospective data collection, to confirm safety and performance of the device.
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
. Subjects aged 18 years or older at the time of signing the informed consent form.
. Subjects undergoing surgical repair of an acute peripheral nerve injury as follows:
. Digital sensory nerve with associated tendon injury, OR
. Digital sensory nerve without tendon injury.
. Nerve must be completely transected and appropriate for primary repair.
. Nerve ends can be reapproximated without excessive tension and without the need for nerve grafting.
. Wound can be adequately cleaned and has sufficient healthy soft tissue to allow primary closure without adjunctive soft tissue procedures.
. Nerve injury is deemed by the surgeon to be suitable for repair using COAPTIUM® CONNECT.
Exclusion criteria
. Known or suspected hypersensitivity to any constituents of the product, including the polymer (Aminated polyglycerol sebacate acrylate) or the additive FD\&C Blue No. 1 Dye (brilliant blue FCF);
. Known diagnosis of peripheral neuropathy;
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.