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SECURE Post-Market Study

NCT07756489 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 65

Last updated 2026-08-10

No results posted yet for this study

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.

Conditions

  • Acute Peripheral Nerve Injuries
  • Digital Nerve Injury

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.

Sponsors & Collaborators

  • Tissium

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-10-31
Primary Completion
2028-04-30
Completion
2028-10-31
FDA Device
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07756489 on ClinicalTrials.gov