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NOT YET RECRUITING
NCT07756489
NA

SECURE Post-Market Study

Sponsor: Tissium

View on ClinicalTrials.gov

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.

Official title: SECURE Post-Market Study (PMS): Atraumatic Sutureless Nerve Repair - Evaluation of COAPTIUM CONNECT in a REal-World Clinical Setting

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

65

Start Date

2026-10

Completion Date

2028-10

Last Updated

2026-10-01

Healthy Volunteers

No

Interventions

DEVICE

COAPTIUM® CONNECT

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.