SECURE Post-Market Study

ConditionDigital Nerve Injury

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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

COAPTIUM® CONNECT
Device
COAPTIUM® CONNECT with TISSIUM® LIGHT is indicated for the sutureless repair of peripheral nerve injuries not in continuity in which a gap closure ≤ 1 cm is present or can be achieved with flexion of the extremity.

Treatment groups

65 Participants

are divided into 1 treatment group

Group A: COAPTIUM® CONNECTExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Sensory Recovery at 6-Months

Rate of higher threshold meaningful recovery (HTMR) at 6 months post-surgery

Time frame

6-Months

Secondary outcomes

Sensory Recovery at 12-Months

Rate of higher threshold meaningful recovery (HTMR) at 12 months post-surgery

Time frame

12-Months

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Tissium

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: