Digital Nerve InjurySECURE PMSNCT07756489
SECURE Post-Market Study
A study testing COAPTIUM® CONNECT in people with Digital Nerve Injury, run by Tissium.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Digital Nerve Injury
- What is being tested?
- COAPTIUM® CONNECT
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- No sites listed yet
- Study dates
- Oct 2026to Oct 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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;
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- 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;
- Diagnosis of type 1 diabetes mellitus or uncontrolled Type 2 diabetes mellitus (at the discretion of the investigator);
- 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;
- Previous injury, surgery, pathology involving the same nerve or extremity;
- Active infection at the surgical site;
- In the opinion of the Investigator, the subject is not a suitable candidate for the clinical investigation.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
- Conditions
- Digital Nerve Injury
- Being tested
- COAPTIUM® CONNECT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COAPTIUM® CONNECTDevice
Also called COAPTIUM® CONNECT with TISSIUM® LIGHT
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.
| Study group | Role | What they receive |
|---|---|---|
| COAPTIUM® CONNECT | Experimental | Nerve Coaptation Device Receives: Device: COAPTIUM® CONNECT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensory Recovery at 6-Months
Rate of higher threshold meaningful recovery (HTMR) at 6 months post-surgery
Measured: 6-Months
Secondary outcomes (1)
Sensory Recovery at 12-Months
Rate of higher threshold meaningful recovery (HTMR) at 12 months post-surgery
Measured: 12-Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2026
- Study startOct 2026 (estimated)
- Primary completionApr 2028 (estimated)
- Study completionOct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Digital Nerve InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 65 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tissium
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07756489
- Sponsor's protocol ID
- PF00004-CLPR-003
- Acronym
- SECURE PMS
- Status last verified
- Aug 2026
- First submitted
- 4 Aug 2026
- Last updated
- 1 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SECURE Post-Market Study (PMS): Atraumatic Sutureless Nerve Repair - Evaluation of COAPTIUM CONNECT in a REal-World Clinical Setting
- ClinicalTrials.gov ID
- NCT07756489
- Acronym / sponsor ID
- SECURE PMS / PF00004-CLPR-003
- Conditions
- Digital Nerve Injury
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 65 participants (estimated)
- Lead sponsor
- TissiumIndustry (pharma, biotech, devices)
- Study start
- Oct 2026 (estimated)
- Primary completion
- Apr 2028 (estimated)
- Study completion
- Oct 2028 (estimated)
- First posted
- 10 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| COAPTIUM® CONNECT | Experimental | Device: COAPTIUM® CONNECTNerve Coaptation Device |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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:
- 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.
Key exclusion criteria (21 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| COAPTIUM® CONNECTAlso: COAPTIUM® CONNECT with TISSIUM® LIGHTCOAPTIUM® 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. | Device | COAPTIUM® CONNECT |
Primary outcome
Sensory Recovery at 6-Months
Time frame: 6-Months
Rate of higher threshold meaningful recovery (HTMR) at 6 months post-surgery
1 secondary outcome
Sensory Recovery at 12-Months
Time frame: 12-Months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing COAPTIUM® CONNECT in people with Digital Nerve Injury, run by Tissium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Raicca Haqqi (617-875-5120, rhaqqi@tissium.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensory Recovery at 6-Months (time frame: 6-Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2026; AzTrials last refreshed its copy on 28 Oct 2026.