SECURE Post-Market Study (SECURE PMS)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Digital Nerve Injury; Acute Peripheral Nerve Injuries
• Intervention / Treatment: Device: COAPTIUM® CONNECT

• Study Type: Interventional
• Enrollment (Estimated): 65
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Raicca Haqqi; Phone Number: 617-875-5120; Email: rhaqqi@tissium.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Subjects aged 18 years or older at the time of signing the informed consent form.

2. Subjects undergoing surgical repair of an acute peripheral nerve injury as follows:

   1. Digital sensory nerve with associated tendon injury, OR
   2. Digital sensory nerve without tendon injury.
3. Nerve must be completely transected and appropriate for primary repair.
4. Nerve ends can be reapproximated without excessive tension and without the need for nerve grafting.
5. Wound can be adequately cleaned and has sufficient healthy soft tissue to allow primary closure without adjunctive soft tissue procedures.
6. Nerve injury is deemed by the surgeon to be suitable for repair using COAPTIUM® CONNECT.
7. Subject is willing and able to provide written informed consent prior to any study specific procedures.
8. Subject is willing and able to complete all required visits and procedures at baseline, 1 month, 3 months, 6 months, and 12 months.

Exclusion Criteria:

1. 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);
2. Known diagnosis of peripheral neuropathy;
3. Any injury requiring revascularization due to critical ischemia from damage to the blood vessels;
4. Subject's traumatic lesion is older than 14 days at the time of surgery;
5. Use of photosensitizing medications at the time of informed consent.
6. Concomitant neuromodulator medication;
7. Life expectancy less than 1 year;
8. History of neuropathic pain in the affected extremity;
9. History of injury to the nerve being studied;
10. Missing contralateral digit or history of injury to the contralateral digit (comparison/control area);
11. Unwillingness/inability to follow postoperative instructions/follow-up visits;
12. Concomitant intake of systemic immunosuppressive medications, steroids (>20mg of prednisone /day or equivalent) and chemotherapy;
13. Prior radiation therapy to the surgical site;
14. Pregnancy detected by a positive pregnancy test or planned pregnancy during the study period or breast-feeding women;
15. History of chronic ischemic disease involving the affected limb;
16. Diagnosis of type 1 diabetes mellitus or uncontrolled Type 2 diabetes mellitus (at the discretion of the investigator);

17. Subject is currently participating in a study involving an investigational device/drug that has not reached its primary endpoints or would interfere with the study endpoints.

    Note: Trials requiring extended follow-up for products that were investigational, but have since become commercially available, are not considered investigational trials;

18. Previous injury, surgery, pathology involving the same nerve or extremity;
19. Active infection at the surgical site;
20. In the opinion of the Investigator, the subject is not a suitable candidate for the clinical investigation.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: COAPTIUM® CONNECT; Nerve Coaptation Device	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.; Other Names: COAPTIUM® CONNECT with TISSIUM® LIGHT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensory Recovery at 6-Months	Rate of higher threshold meaningful recovery (HTMR) at 6 months post-surgery	6-Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensory Recovery at 12-Months	Rate of higher threshold meaningful recovery (HTMR) at 12 months post-surgery	12-Months

Collaborators and Investigators

• Sponsor: Tissium

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): October 1, 2028

Study Registration Dates

• First Submitted: August 4, 2026
• First Submitted That Met QC Criteria: August 4, 2026
• First Posted (Actual): August 10, 2026

Study Record Updates

• Last Update Posted (Actual): August 10, 2026
• Last Update Submitted That Met QC Criteria: August 4, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: PF00004-CLPR-003

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No