SECURE Post-Market Study
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorTissium
About this trial
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.
Eligibility criteria
Qualifiers
Subjects aged 18 years or older at the time of signing the informed consent form.
Digital sensory nerve with associated tendon injury, OR
Digital sensory nerve without tendon injury.
Nerve must be completely transected and appropriate for primary repair.
Disqualifiers
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;
Any injury requiring revascularization due to critical ischemia from damage to the blood vessels;
Subject's traumatic lesion is older than 14 days at the time of surgery;
Trial design
Treatments tested in this trial
- COAPTIUM® CONNECT
Treatment groups
65 Participants
are divided into 1 treatment groupLocations
Sponsors and collaborators
Source ClinicalTrials.gov