SECURE Post-Market Study

NCT07756489 | Not Yet Recruiting FDA Device

• 1 other identifier: PF00004-CLPR-003
• Study Type: interventional
• Target: 65
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (1)

• Sensory Recovery at 6-Months

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

  6-Months

Secondary Outcomes (1)

• Sensory Recovery at 12-Months

  12-Months

Study Arms (1)

COAPTIUM® CONNECT

EXPERIMENTAL

Nerve Coaptation Device

Device: COAPTIUM® CONNECT

Interventions

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.

Also known as: COAPTIUM® CONNECT with TISSIUM® LIGHT

COAPTIUM® CONNECT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Subject is willing and able to provide written informed consent prior to any study specific procedures.
• Subject is willing and able to complete all required visits and procedures at baseline, 1 month, 3 months, 6 months, and 12 months.

You may not qualify if:

• 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;
• Use of photosensitizing medications at the time of informed consent.
• Concomitant neuromodulator medication;
• Life expectancy less than 1 year;
• History of neuropathic pain in the affected extremity;
• History of injury to the nerve being studied;
• Missing contralateral digit or history of injury to the contralateral digit (comparison/control area);
• Unwillingness/inability to follow postoperative instructions/follow-up visits;
• Concomitant intake of systemic immunosuppressive medications, steroids (\>20mg of prednisone /day or equivalent) and chemotherapy;
• Prior radiation therapy to the surgical site;
• Pregnancy detected by a positive pregnancy test or planned pregnancy during the study period or breast-feeding women;
• History of chronic ischemic disease involving the affected limb;

Sponsors & Collaborators

• Tissium: lead

Central Study Contacts

Raicca Haqqi

CONTACT

617-875-5120; rhaqqi@tissium.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2026
• First Posted: August 10, 2026
• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): October 1, 2028
• Last Updated: August 10, 2026

Record last verified: 2026-08