Digital Nerve InjuryNCT05343143
NeuraGen 3D Pilot Study
A study testing NeuraGen 3D Nerve Guide Matrix in people with Digital Nerve Injury, run by Integra LifeSciences Corporation at 4 sites in United States.
Trial summary
This is a 10-subject, 12-month follow-up, prospective, multi-center, open-label, single arm clinical trial designed to understand the initial performance characteristics and confirm the safety profile of the NeuraGen 3D Nerve Guide Matrix. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Digital Nerve Injury
- What is being tested?
- NeuraGen 3D Nerve Guide Matrix
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 4 sitesUnited States
- Study dates
- 15 May 2022to 13 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject has one, single level, digital nerve injury that:
- Involves complete traumatic nerve section of the common or proper nerve of the palmar aspect of hand.
- Occurred less than and up to 21 days prior to the nerve repair surgery detailed in this protocol.
- In the opinion of the investigator, has a gap which can be easily closed without placing undue tension on the ends of the nerves with the device (i.e., the gap must be shorter than the maximum length of the device being used).
- Subject has adequate vascular perfusion of the target hand as assessed by the investigator
- Subject can accommodate immobilization of the injured hand post-operatively.
- Subject's contralateral hand is intact and of normal function.
Who cannot join
- Nerve to be repaired is a mixed motor nerve
- Subject has a known history of hypersensitivity to bovine-derived or chondroitin-based materials.
- Subject's hand injury is of a nature which could negatively impact healing of the target nerves such as a crush or avulsion injury, incomplete transection of the target nerve, or complete separation of the digit affiliated with the target nerve.
- Subject's hand injury or general physical presentation of the target hand is of a nature which would prevent adequate measurement of functional nerve healing assessments.
- Subject has gross contamination of the wound in which the nerve to be studied in this protocol resides (i.e., presence of glass, metal, other large debris).
- Subject has pre-existing nerve lesions or known diagnosis of compressive neuropathy of median or ulnar nerves (i.e., Cubital or carpal tunnel syndrome).
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- Subject has an active infection of the area around the nerve defect.
- Subject has unstable vital signs.
- Subject has a disorder known to affect the peripheral nervous system (PNS) such as:
- Subject has any systemic disease which may confound study results Subject is known to have received immunosuppressive or antineoplastic agents or systemic steroids within 7 days of the study.
- Subject is known to have had or will require radiation or other therapy to the target hand or limb which may impact nerve healing.
- Subject has a history of injury to or a congenital abnormality of the target hand or limb which may impact nerve healing or confound study results.
- Subject is pregnant (determined either by the subject's confirmation or a formal test).
- Subject has participated in another clinical trial using an investigational drug or device within 30 days prior to the nerve repair surgery detailed in this protocol.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210
Duke University
Durham, North Carolina, 27708
Hospital for Special Surgery
New York, New York, 10021
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15261
About this study
Official title: An Open-Label, Multicenter, Pilot Study to Evaluate the Performance and Safety of NeuraGen® 3D Nerve Guide Matrix.
This is a 10-subject, 12-month follow-up, prospective, multi-center, open-label, single arm clinical trial designed to understand the initial performance characteristics and confirm the safety profile of the NeuraGen 3D Nerve Guide Matrix.
Read the detailed description
The NeuraGen® 3D Nerve Guide Matrix is indicated for the repair of peripheral nerve discontinuities where tension-free closure can be achieved by flexion of the digit or extremity.
- Conditions
- Digital Nerve Injury
- Being tested
- NeuraGen 3D Nerve Guide Matrix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeuraGen 3D Nerve Guide MatrixDevice
Integra NeuraGen 3D Nerve Guide Matrix is a resorbable implant for the repair of peripheral nerve gaps.
| Study group | Role | What they receive |
|---|---|---|
| NeuraGen 3D Nerve Guide Matrix | Other | Integra NeuraGen 3D Nerve Guide Matrix is a resorbable implant for the repair of peripheral nerve gaps. Receives: Device: NeuraGen 3D Nerve Guide Matrix |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary objective of this study is to evaluate return to sensory recovery with the NeuraGen 3D Nerve Guide Matrix in a small group of subjects with primary nerve injury of the hand.(s2PD) at each post-operative timepoint of the study.
To be assessed during in office visits using the DeMayo 2-point discrimination device
Measured: 12 Months
Secondary outcomes (7)
Moving 2 Point Discrimination Test (m2PD) at each post-operative timepoint of the study:
To be assessed during in office visits using the DeMayo 2-point discrimination device
Measured: 12 Months
Grip Strength Test at each post-operative timepoint of the study
To be assessed during in office visits using the Camry hand dynamometer
Measured: 12 Months
Pinch Strength Test at each post-operative timepoint of the study
To be assessed during in office visits using the Baseline Digital Pinch Gauge
Measured: 12 Months
Semmes-Weinstein Monofilament Testing at each post-operative timepoint of the study
To be assessed during in office visits using the Baseline Tactile Semmes-Weinstein monofilament
Measured: 12 Months
Disabilities of the Arm, Shoulder and Hand (DASH) Score at each post-operative timepoint of the study
To be completed via in office visits
Measured: 12 Months
Michigan Hand Outcomes Questionnaire (MHQ) at each post-operative timepoint of the study
To be completed via in office visits
Measured: 12 Months
Continuous Visual Analog Scale for Pain at each post-operative timepoint of the study
0-100 Scale, 0-no pain at all, 100- worst possible pain. To be completed via in office visits
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 posted25 Apr 2022
- Study start15 May 2022
- Primary completion11 Jul 2023
- Study completion13 May 2024
Why it stopped: Slow Enrollment, Sponsor Decision
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
- Model description
- single arm investigational clinical trial
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Integra LifeSciences Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Maria Leonard, Study director, Integra LifeSciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05343143
- Sponsor's protocol ID
- T-NERVE3D-001
- Status last verified
- May 2024
- First submitted
- 18 Apr 2022
- Last updated
- 16 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Multicenter, Pilot Study to Evaluate the Performance and Safety of NeuraGen® 3D Nerve Guide Matrix.
- ClinicalTrials.gov ID
- NCT05343143
- Acronym / sponsor ID
- T-NERVE3D-001
- Conditions
- Digital Nerve Injury
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow Enrollment, Sponsor Decision
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Integra LifeSciences CorporationIndustry (pharma, biotech, devices)
- Study start
- 15 May 2022 (actual)
- Primary completion
- 11 Jul 2023 (actual)
- Study completion
- 13 May 2024 (actual)
- First posted
- 25 Apr 2022 (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.
This is a 10-subject, 12-month follow-up, prospective, multi-center, open-label, single arm clinical trial designed to understand the initial performance characteristics and confirm the safety profile of the NeuraGen 3D Nerve Guide Matrix.
Detailed description
The NeuraGen® 3D Nerve Guide Matrix is indicated for the repair of peripheral nerve discontinuities where tension-free closure can be achieved by flexion of the digit or extremity.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- single arm investigational clinical trial
| Arm | Type | Receives |
|---|---|---|
| NeuraGen 3D Nerve Guide Matrix | Other | Device: NeuraGen 3D Nerve Guide MatrixIntegra NeuraGen 3D Nerve Guide Matrix is a resorbable implant for the repair of peripheral nerve gaps. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Subject has one, single level, digital nerve injury that:
- Involves complete traumatic nerve section of the common or proper nerve of the palmar aspect of hand.
- Occurred less than and up to 21 days prior to the nerve repair surgery detailed in this protocol.
- In the opinion of the investigator, has a gap which can be easily closed without placing undue tension on the ends of the nerves with the device (i.e., the gap must be shorter than the maximum length of the device being used).
- Subject has adequate vascular perfusion of the target hand as assessed by the investigator
Key exclusion criteria (14 listed)
- Nerve to be repaired is a mixed motor nerve
- Subject has a known history of hypersensitivity to bovine-derived or chondroitin-based materials.
- Subject's hand injury is of a nature which could negatively impact healing of the target nerves such as a crush or avulsion injury, incomplete transection of the target nerve, or complete separation of the digit affiliated with the target nerve.
- Subject's hand injury or general physical presentation of the target hand is of a nature which would prevent adequate measurement of functional nerve healing assessments.
- Subject has gross contamination of the wound in which the nerve to be studied in this protocol resides (i.e., presence of glass, metal, other large debris).
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 |
|---|---|---|
| NeuraGen 3D Nerve Guide MatrixIntegra NeuraGen 3D Nerve Guide Matrix is a resorbable implant for the repair of peripheral nerve gaps. | Device | NeuraGen 3D Nerve Guide Matrix |
Primary outcome
The primary objective of this study is to evaluate return to sensory recovery with the NeuraGen 3D Nerve Guide Matrix in a small group of subjects with primary nerve injury of the hand.(s2PD) at each post-operative timepoint of the study.
Time frame: 12 Months
To be assessed during in office visits using the DeMayo 2-point discrimination device
7 secondary outcomes
Moving 2 Point Discrimination Test (m2PD) at each post-operative timepoint of the study:
Time frame: 12 Months
Grip Strength Test at each post-operative timepoint of the study
Time frame: 12 Months
Pinch Strength Test at each post-operative timepoint of the study
Time frame: 12 Months
Semmes-Weinstein Monofilament Testing at each post-operative timepoint of the study
Time frame: 12 Months
Disabilities of the Arm, Shoulder and Hand (DASH) Score at each post-operative timepoint of the study
Time frame: 12 Months
Michigan Hand Outcomes Questionnaire (MHQ) at each post-operative timepoint of the study
Time frame: 12 Months
Continuous Visual Analog Scale for Pain at each post-operative timepoint of the study
Time frame: 12 Months
Results and safety
The study was stopped early (reason given: Slow Enrollment, Sponsor Decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2024.
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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. This study is not recruiting at the moment.
Maria Leonard study director
Integra LifeSciences
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NeuraGen 3D Nerve Guide Matrix in people with Digital Nerve Injury, run by Integra LifeSciences Corporation at 4 sites in United States.
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 7 inclusion and 14 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: stopped early, as of the sponsor's last update on 16 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study was stopped early (reason given: Slow Enrollment, Sponsor Decision). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary objective of this study is to evaluate return to sensory recovery with the NeuraGen 3D Nerve Guide Matrix in a small group of subjects with primary nerve injury of the hand.(s2PD) at each post-operative timepoint of the study. (time frame: 12 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 16 May 2024.