Peripheral Nerve InjuriesNCT05339594
REINVENT Registry (Registry of the Nerve Gap Repair From Integra)
An observational study of Peripheral Nerve Injuries, run by Integra LifeSciences Corporation at 6 sites in United States.
Trial summary
This is a prospective, multi-center, observational registry designed to evaluate two of Integra's collagen nerve gap repair products (NeuraGen® Nerve Guide and NeuraGen® 3D Nerve Guide Matrix). This registry will collect data on the outcome measures throughout the follow-up period for each patient. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Nerve Injuries
- What is being tested?
- NeuraGen and NeuraGen 3D
- Type of treatment
- Medical device
- How many people
- 17 participants
- Where
- 6 sitesUnited States
- Study dates
- 30 May 2022to 3 Jun 2024
- How long will I take part?
- 18 Months
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All subjects with have had a repair of a peripheral nerve injury in the upper extremity distal to the palmer crease of the hand and without previous repairs.
Who may be able to join
- Subject has undergone nerve gap repair utilizing NeuraGen or NeuraGen 3D
- Subject is willing and able to comply with postoperative procedures and visits such as immobilization, etc.
- Subject had a digital nerve injury that occurred up to 90 days prior to the nerve gap repair surgery detailed in this protocol.
- Subject had digital nerve injury(ies) that involve(s) complete nerve section of a sensory nerve of the palmar aspect of the hand that is distal to the palmer crease of the hand.
- Subject requires only a single repair per proper digital nerve branch
Who cannot join
- Subject has a known history of hypersensitivity to bovine-derived or chondroitin-based materials.
- 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.
- 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 has debris due to injury of the affected hand where contamination cannot be ruled out.
- Subject has pre-existing nerve lesions or known diagnosis of compressive neuropathy of median or ulnar nerves (i.e., Cubital or carpal tunnel syndrome)
- Subject has an infection of the area around the nerve defect.
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- Subjects with diagnosed Peripheral Vascular Disease and Peripheral Arterial Disease
- 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 or contralateral hand or limb which may impact nerve healing or confound study results.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
University of Virginia
Charlottesville, Virginia, 22903
Indiana Hand to Shoulder Center
Indianapolis, Indiana, 46260
West Virginia University
Morgantown, West Virginia, 26501
University of Pittsburgh Medical Center (UPMC)
Pittsburgh, Pennsylvania, 15213
Washington University at St Louis
St Louis, Missouri, 63110
Montefiore Medical Center
The Bronx, New York, 10461
About this study
Official title: Post-Market Clinical Follow-up Registry of Patients Requiring Nerve Gap Repair From Integra
This is a prospective, multi-center, observational registry designed to evaluate two of Integra's collagen nerve gap repair products (NeuraGen® Nerve Guide and NeuraGen® 3D Nerve Guide Matrix). This registry will collect data on the outcome measures throughout the follow-up period for each patient. Data will be collected per standard of care.
Read the detailed description
Integra NeuraGen Nerve Guide has been approved for clinical use since 2001 and has become a recognized clinical option for clinical nerve repair for the type of injuries evaluated in this registry. Integra NeuraGen Nerve Guide is used in this registry as a comparator to a next-generation advanced nerve guide, Integra NeuraGen 3D Nerve Guide Matrix, that is based on the original Integra NeuraGen Nerve Guide technology but contains a regenerative matrix in the lumen.
Centers chosen for participation will be current users of Integra's collagen nerve gap repair products listed above.
- Conditions
- Peripheral Nerve Injuries
- Being tested
- NeuraGen, NeuraGen 3D
- Keywords
- Digital Nerve Gap Repair
- Medical subject headings
- Peripheral Nerve Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeuraGenDevice
NeuraGen nerve guide is an absorbable implant for the repair of peripheral nerve gaps.
NeuraGen 3DDevice
NeuraGen 3D Nerve guide matrix is a resorbable implant for the repair of peripheral nerve gaps.
| Study group | Role | What they receive |
|---|---|---|
| NeuraGen Nerve Guide | Integra NeuraGen nerve guide is an absorbable implant for the repair of peripheral nerve gaps. Receives: Device: NeuraGen | |
| NeuraGen 3D Nerve Guide Matrix | Integra NeuraGen 3D Nerve Guide Matrix is a resorbable implant for the repair of peripheral nerve gaps. Receives: Device: NeuraGen 3D |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary clinical outcome measure is an evaluation of meaningful recovery as expressed by the Medical Research Council (MRC) scale as determined by the 2-point discrimination test (2PD).
The primary endpoint success is when each subject reaches meaningful recovery, which is defined as an MRC score of S3+ or S4 (fair, good or excellent 2PD) of the pulp assessment of the distal phalanx of the affected digit(s).
Measured: 18 Months
Secondary outcomes (4)
Evaluation of Static 2 Point Discrimination (s2PD) using DeMayo 2-point discrimination device
To be assessed via in office visits
Measured: 18 Months
Evaluation of Moving 2PD using DeMayo 2-point discrimination device
To be assessed via in office visits
Measured: 18 months
Evaluation of Michigan Hand and Outcomes Questionnaire (MHQ)
To be assessed via web based tool during at home visits
Measured: 15 Months
Evaluation of Visual Analog Scale for Pain (VAS)
To be assessed via web based tool during at home visits
Measured: 15 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2022
- Study start30 May 2022
- Primary completion3 Jun 2024
- Study completion3 Jun 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 Peripheral Nerve InjuriesStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 17 participants (actual)
- Target duration
- 18 Months
Sponsor and investigators
- Lead sponsor
- Integra LifeSciences Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Maria Leonard, BSN,RN,CTBS, Study director, Integra LifeSciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05339594
- Sponsor's protocol ID
- T-INVENT-001
- Status last verified
- Jul 2024
- First submitted
- 6 Apr 2022
- Last updated
- 11 Jul 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 11 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Market Clinical Follow-up Registry of Patients Requiring Nerve Gap Repair From Integra
- ClinicalTrials.gov ID
- NCT05339594
- Acronym / sponsor ID
- T-INVENT-001
- Conditions
- Peripheral Nerve Injuries
- Keywords
- Digital Nerve Gap Repair
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Slow Enrollment, Sponsor Decision
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Integra LifeSciences CorporationIndustry (pharma, biotech, devices)
- Study start
- 30 May 2022 (actual)
- Primary completion
- 3 Jun 2024 (actual)
- Study completion
- 3 Jun 2024 (actual)
- First posted
- 21 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 prospective, multi-center, observational registry designed to evaluate two of Integra's collagen nerve gap repair products (NeuraGen® Nerve Guide and NeuraGen® 3D Nerve Guide Matrix). This registry will collect data on the outcome measures throughout the follow-up period for each patient. Data will be collected per standard of care.
Detailed description
Integra NeuraGen Nerve Guide has been approved for clinical use since 2001 and has become a recognized clinical option for clinical nerve repair for the type of injuries evaluated in this registry. Integra NeuraGen Nerve Guide is used in this registry as a comparator to a next-generation advanced nerve guide, Integra NeuraGen 3D Nerve Guide Matrix, that is based on the original Integra NeuraGen Nerve Guide technology but contains a regenerative matrix in the lumen.
Centers chosen for participation will be current users of Integra's collagen nerve gap repair products listed above.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 18 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NeuraGen Nerve Guide | – | Device: NeuraGenIntegra NeuraGen nerve guide is an absorbable implant for the repair of peripheral nerve gaps. |
| NeuraGen 3D Nerve Guide Matrix | – | Device: NeuraGen 3DIntegra NeuraGen 3D Nerve Guide Matrix is a resorbable implant for the repair of peripheral nerve gaps. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All subjects with have had a repair of a peripheral nerve injury in the upper extremity distal to the palmer crease of the hand and without previous repairs.
Key inclusion criteria (5 listed)
- Subject has undergone nerve gap repair utilizing NeuraGen or NeuraGen 3D
- Subject is willing and able to comply with postoperative procedures and visits such as immobilization, etc.
- Subject had a digital nerve injury that occurred up to 90 days prior to the nerve gap repair surgery detailed in this protocol.
- Subject had digital nerve injury(ies) that involve(s) complete nerve section of a sensory nerve of the palmar aspect of the hand that is distal to the palmer crease of the hand.
- Subject requires only a single repair per proper digital nerve branch
Key exclusion criteria (10 listed)
- Subject has a known history of hypersensitivity to bovine-derived or chondroitin-based materials.
- 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.
- 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 has debris due to injury of the affected hand where contamination cannot be ruled out.
- Subject has pre-existing nerve lesions or known diagnosis of compressive neuropathy of median or ulnar nerves (i.e., Cubital or carpal tunnel syndrome)
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 |
|---|---|---|
| NeuraGenNeuraGen nerve guide is an absorbable implant for the repair of peripheral nerve gaps. | Device | NeuraGen Nerve Guide |
| NeuraGen 3DNeuraGen 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 clinical outcome measure is an evaluation of meaningful recovery as expressed by the Medical Research Council (MRC) scale as determined by the 2-point discrimination test (2PD).
Time frame: 18 Months
The primary endpoint success is when each subject reaches meaningful recovery, which is defined as an MRC score of S3+ or S4 (fair, good or excellent 2PD) of the pulp assessment of the distal phalanx of the affected digit(s).
4 secondary outcomes
Evaluation of Static 2 Point Discrimination (s2PD) using DeMayo 2-point discrimination device
Time frame: 18 Months
Evaluation of Moving 2PD using DeMayo 2-point discrimination device
Time frame: 18 months
Evaluation of Michigan Hand and Outcomes Questionnaire (MHQ)
Time frame: 15 Months
Evaluation of Visual Analog Scale for Pain (VAS)
Time frame: 15 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 11 Jul 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, BSN,RN,CTBS study director
Integra LifeSciences
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peripheral Nerve Injuries, run by Integra LifeSciences Corporation at 6 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 5 inclusion and 10 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 11 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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 clinical outcome measure is an evaluation of meaningful recovery as expressed by the Medical Research Council (MRC) scale as determined by the 2-point discrimination test (2PD). (time frame: 18 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 11 Jul 2024.