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Can a Glue-Like device mend severed nerves without stitches?

NCT ID NCT07756489

Disease control Sponsor: Tissium Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 10, 2026 · Last updated Aug 11, 2026 · Updated 1 time

Summary

This study evaluates a device called COAPTIUM CONNECT, which repairs severed peripheral nerves in the hand without stitches. The trial will enroll 65 adults with acute digital nerve injuries and measure sensory recovery at 6 and 12 months after surgery. The goal is to confirm the device's safety and effectiveness in a real-world setting, potentially offering a less traumatic alternative to traditional nerve repair.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
COAPTIUM CONNECT with TISSIUM LIGHT, a sutureless nerve repair device
What this could lead to
If successful, this device could offer a faster, less traumatic way to repair severed hand nerves, potentially improving sensory recovery and reducing complications compared to traditional sutures.
What could go wrong
This is a post-market study, meaning the device is already available, but real-world evidence may reveal unexpected issues. The trial is relatively small (65 participants) and focuses on short-term sensory recovery, so long-term benefits or risks remain uncertain.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 65 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Oct 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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How to take part

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  1. The official record

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    Open the record ↗

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