Peripheral Nerve InjuriesNeuroSpan-1NCT06529835
A Comparison of NeuroSpan Bridge, NeuraGen Nerve Guide, and Nerve Autograft for Peripheral Nerve Repair
A study testing NeuroSpan Bridge, NeuroGen Nerve Guide and Nerve Autograft in people with Peripheral Nerve Injuries, run by Auxilium Biotechnologies at 8 sites in United States.
Trial summary
This is a multicenter, prospective, randomized, subject and evaluator blinded clinical trial to asses the efficacy of Auxilium's NeuroSpan Bridge. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Peripheral Nerve Injuries
- What is being tested?
- NeuroSpan Bridge, NeuroGen Nerve Guide and Nerve Autograft
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 8 sitesUnited States
- Study dates
- 21 Mar 2025to Aug 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18 to 80 with upper or lower extremity nerve injury with a gap of 0.5 to 3.0 cm.
- Nerve diameter at injury site ≤3mm.
- Nerve injury location is the arm from the shoulder to the wrist, including the hand or the leg from the hip to the ankle including the foot.
- For Motor Nerve Injuries: Distance from site of injury to the nearest innervated muscle: ≤100mm
- For Sensory and Mixed Nerve injuries: Distance from the site of injury to the nearest sensory nerve target: ≤250mm
- Repair must take place within 3 months from injury
- No contraindications to surgical repair (e.g., risk of concurrent infection, dog bite)
Who cannot join
- Previous history of nerve repair attempt at the treated nerve.
- Concurrent disease that reduces nerve regeneration: diabetes, previous diagnosis of non-traumatic peripheral neuropathy, chemotherapy treatment, other causes of peripheral neuropathy.
- Allergy to Bovine products such as Bovine Collagen Nerve Cuff.
- Pregnancy or planning to become pregnant
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
8 sites in 1 country
United States8 sites, 8 recruiting
- Recruiting
Medstar Union Memorial Hospital- The Curtis National Hand Center
Baltimore, Maryland, 21218
Ike Fleming, 410-554-2486, Ike.C.Fleming@Medstar.net
Carly Kingston, Carly.Q.Kingston@medstar.net
- Recruiting
OSU Wexner Medical Center
Columbus, Ohio, 43212
Emily Rice, 614-293-5871, Emily.Rice2@osumc.edu
Irene Kaptsan, Irina.Kaptsan@osumc.edu
- Recruiting
UT Health Houston
Houston, Texas, 77030
Tien Do, 281-857-2353, Tien.Do@uth.tmc.edu
Jeffrey Trost, MD
- Recruiting
NYU Langone Orthopedic Center
New York, New York, 10003
Ann Hu, 646-501-2180, Ann.Hu@nyulangone.org
Jaques Hacquebord, M.D.
- Recruiting
University of Pennsylvania- Penn Presbyterian Medical Center
Philadelphia, Pennsylvania, 19104
Ellen Stinger, 215-273-5064, Ellen.Stinger@Pennmedicine.upenn.edu
Annamarie Horan, HoranA@pennmedicine.upenn.edu
- Recruiting
The San Antonio Orthopaedic Group (TSAOG Orthopaedics)
San Antonio, Texas, 78258
Amanda Strickland, 509-951-1382, astrickland@tsaog.com
Monica Contreras, mcontreras@tsaog.com
- Recruiting
UC San Diego Health
San Diego, California, 92103
Dominic Baun, 858-534-8268, jbaun@health.ucsd.edu
Abigail Yap, abyap@health.ucsd.edu
- Recruiting
UCSF Orthopedic Institute
San Francisco, California, 94158
Aamna Haq, 415-514-8707, aamna.haq@ucsf.edu
Jillene Sturgess-Daprato, Jillene.Sturgess@ucsf.edu
About this study
Official title: A Comparison of NeuroSpan Bridge, NeuraGen Nerve Guide, and Nerve Autograft for Peripheral Nerve Repair (NeuroSpan-1)
This is a multicenter, prospective, randomized, subject and evaluator blinded clinical trial to asses the efficacy of Auxilium's NeuroSpan Bridge.
- Conditions
- Peripheral Nerve Injuries
- Being tested
- NeuroSpan Bridge, NeuroGen Nerve Guide, Nerve Autograft
- 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.
NeuroSpan BridgeDevice
The implant is used to connect peripheral nerve discontinuities. It is designed to be an interface between the nerve and surrounding tissue and to create a conduit for axonal growth across a nerve gap.
The NeuroSpan Bridge is a novel scaffold to support regeneration that mimics the natural bio- architecture, providing multiple channels that are strictly linear so that axonal position is accurately maintained across the full length of the scaffold - over any length - to re-enter the distal nerve stump.
NeuroGen Nerve GuideDevice
The NeuraGen Nerve Guide is a resorbable implant for the repair of 0.5-1.0cm peripheral nerve discontinuities. NeuraGen Nerve Guide provides a protective environment for peripheral nerve repair after injury. It is designed to be an interface between the nerve and surrounding tissue and to create a conduit for axonal growth across a nerve gap. The semi-permeable type 1 collagen membrane allows for controlled resorption, appropriate nutrient diffusion and retention of representative Nerve Growth Factor.
Nerve AutograftDevice
A nerve autograft is a surgical procedure that involves transplanting a segment of a patient's own sensory nerve tissue to repair a damaged peripheral nerve injury measuring 1.1-3.0cm. It is designed to be an interface between the nerve and surrounding tissue and to create a conduit for axonal growth across a nerve gap
| Study group | Role | What they receive |
|---|---|---|
| NeuroGen Nerve Guide | Active comparator | The control arm will comprise of subjects requiring injury repair of 0.5-1.0cm. These subjects will receive the NeuraGen Nerve Guide. Receives: Device: NeuroSpan Bridge; Device: NeuroGen Nerve Guide |
| Nerve Autograft | Active comparator | The control arm will comprise of subjects requiring injury repair of 1.1-3.0cm. These subjects will receive the Nerve Autograft. Receives: Device: NeuroSpan Bridge; Device: Nerve Autograft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy- Static two-point discrimination (s2PD) measured at 12 months.
This endpoint will examine the change in Static two-point discrimination (s2PD) measured at 12 months.
Measured: 12 months
Safety- Complications and adverse events including infections, inflammation, tissue rejections, neuroma formation, chronic pain, and device malfunctions occurring between the treatment procedure and the 12-month follow-up visit.
This endpoint will examine complications and adverse events including infections, inflammation, tissue rejections, neuroma formation, chronic pain, and device malfunctions occurring between the treatment procedure and the 12-month follow-up visit.
Measured: 12 months
Secondary outcomes (6)
Motor function assessed by the British Medical Research Council grading system (categories 0, 1, 2, 3, 4, 5) at 12 months.
This endpoint will examine motor function assessed by the British Medical Research Council grading system (categories 0, 1, 2, 3, 4, 5) at 12 months.
Measured: 12 months
Sensory function assessed by the British Medical Research Council grading system at 12 months.
This endpoint will examine sensory function assessed by the British Medical Research Council grading system at 12 months.
Measured: 12 months
Moving 2 Point Discrimination test (m2PD) in the target digit at 12 months.
This endpoint will examine Moving 2 Point Discrimination test (m2PD) in the target digit at 12 months.
Measured: 12 months
The summary score from the Disabilities of the Arm Shoulder and Hand (DASH) questionnaire at 12 months.
This endpoint will examine the summary score from the Disabilities of the Arm Shoulder and Hand (DASH) questionnaire at 12 months.
The Disabilities of the Arm Shoulder and Hand (DASH) is a 30-item patient-reported outcome measure utilized to assess symptoms and function of the entire upper extremity. It is scored using the 5-point Likert-Scale measuring from "1" (lowest level of difficulty or severity) to 5" (highest level of difficulty or severity) based on the patient's reported ability to conduct the activities or tasks. A higher score indicates greater disability.
Measured: 12 months
The summary score from the Disabilities of the Arm Shoulder and Hand (DASH) Work Module at 12 months.
This endpoint will examine the summary score from the Disabilities of the Arm Shoulder and Hand (DASH) Work Module at 12 months.
The Disabilities of the Arm Shoulder and Hand (DASH) Work Module is a 4 question patient-reported outcome measure utilized to assess the impact of the patients arm, shoulder, or hand problem on the patients ability to work. It is scored using the 5-point Likert-Scale measuring from "1" (lowest level of difficulty or severity) to 5" (highest level of difficulty or severity) based on the patient's reported ability to conduct the activities or tasks. A higher score indicates greater disability.
Measured: 12 months
The summary score from the Disabilities of the Arm Shoulder and Hand (DASH) Sports/Performing Arts Module at 12 months.
This endpoint will examine the summary score from the Disabilities of the Arm Shoulder and Hand (Dash) Sports/Performing Arts Module at 12 months.
The Disabilities of the Arm Shoulder and Hand (DASH) Sports/Performing Arts Module is a 4 question patient-reported outcome measure utilized to assess the impact of the patients arm, shoulder, or hand problem on their ability to play a musical instrument, participate in sport or both. It is scored using the 5-point Likert-Scale measuring from "1" (lowest level of difficulty or severity) to 5" (highest level of difficulty or severity) based on the patient's reported ability to conduct the activities or tasks. A higher score indicates greater disability.
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 posted31 Jul 2024
- Study start21 Mar 2025
- Primary completionDec 2027 (estimated)
- Study completionAug 2028 (estimated)
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A total of 80 subjects will be enrolled and randomized using a 1:1 ratio.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Auxilium Biotechnologies
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- MCRA
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06529835
- Sponsor's protocol ID
- AUX-NS-001
- Acronym
- NeuroSpan-1
- Status last verified
- Jun 2026
- First submitted
- 22 Jul 2024
- Last updated
- 26 Jun 2026
- 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 26 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of NeuroSpan Bridge, NeuraGen Nerve Guide, and Nerve Autograft for Peripheral Nerve Repair (NeuroSpan-1)
- ClinicalTrials.gov ID
- NCT06529835
- Acronym / sponsor ID
- NeuroSpan-1 / AUX-NS-001
- Conditions
- Peripheral Nerve Injuries
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Auxilium BiotechnologiesIndustry (pharma, biotech, devices)
- Collaborators
- MCRA
- Study start
- 21 Mar 2025 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Aug 2028 (estimated)
- First posted
- 31 Jul 2024 (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 multicenter, prospective, randomized, subject and evaluator blinded clinical trial to asses the efficacy of Auxilium's NeuroSpan Bridge.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- A total of 80 subjects will be enrolled and randomized using a 1:1 ratio.
| Arm | Type | Receives |
|---|---|---|
| NeuroGen Nerve Guide | Active comparator | Device: NeuroSpan Bridge, Device: NeuroGen Nerve GuideThe control arm will comprise of subjects requiring injury repair of 0.5-1.0cm. These subjects will receive the NeuraGen Nerve Guide. |
| Nerve Autograft | Active comparator | Device: NeuroSpan Bridge, Device: Nerve AutograftThe control arm will comprise of subjects requiring injury repair of 1.1-3.0cm. These subjects will receive the Nerve Autograft. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients aged 18 to 80 with upper or lower extremity nerve injury with a gap of 0.5 to 3.0 cm.
- Nerve diameter at injury site ≤3mm.
- Nerve injury location is the arm from the shoulder to the wrist, including the hand or the leg from the hip to the ankle including the foot.
- For Motor Nerve Injuries: Distance from site of injury to the nearest innervated muscle: ≤100mm
- For Sensory and Mixed Nerve injuries: Distance from the site of injury to the nearest sensory nerve target: ≤250mm
Key exclusion criteria (4 listed)
- Previous history of nerve repair attempt at the treated nerve.
- Concurrent disease that reduces nerve regeneration: diabetes, previous diagnosis of non-traumatic peripheral neuropathy, chemotherapy treatment, other causes of peripheral neuropathy.
- Allergy to Bovine products such as Bovine Collagen Nerve Cuff.
- Pregnancy or planning to become pregnant
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 |
|---|---|---|
| NeuroSpan BridgeThe implant is used to connect peripheral nerve discontinuities. It is designed to be an interface between the nerve and surrounding tissue and to create a conduit for axonal growth across a nerve gap. The NeuroSpan Bridge is a novel scaffold to support regeneration that mimics the natural bio- architecture, providing multiple channels that are strictly linear so that axonal position is accurately maintained across the full length of the scaffold - over any length - to re-enter the distal nerve stump. | Device | Nerve Autograft, NeuroGen Nerve Guide |
| NeuroGen Nerve GuideThe NeuraGen Nerve Guide is a resorbable implant for the repair of 0.5-1.0cm peripheral nerve discontinuities. NeuraGen Nerve Guide provides a protective environment for peripheral nerve repair after injury. It is designed to be an interface between the nerve and surrounding tissue and to create a conduit for axonal growth across a nerve gap. The semi-permeable type 1 collagen membrane allows for controlled resorption, appropriate nutrient diffusion and retention of representative Nerve Growth Factor. | Device | NeuroGen Nerve Guide |
| Nerve AutograftA nerve autograft is a surgical procedure that involves transplanting a segment of a patient's own sensory nerve tissue to repair a damaged peripheral nerve injury measuring 1.1-3.0cm. It is designed to be an interface between the nerve and surrounding tissue and to create a conduit for axonal growth across a nerve gap | Device | Nerve Autograft |
Primary outcome
Efficacy- Static two-point discrimination (s2PD) measured at 12 months.
Time frame: 12 months
This endpoint will examine the change in Static two-point discrimination (s2PD) measured at 12 months.
Safety- Complications and adverse events including infections, inflammation, tissue rejections, neuroma formation, chronic pain, and device malfunctions occurring between the treatment procedure and the 12-month follow-up visit.
Time frame: 12 months
This endpoint will examine complications and adverse events including infections, inflammation, tissue rejections, neuroma formation, chronic pain, and device malfunctions occurring between the treatment procedure and the 12-month follow-up visit.
6 secondary outcomes
Motor function assessed by the British Medical Research Council grading system (categories 0, 1, 2, 3, 4, 5) at 12 months.
Time frame: 12 months
Sensory function assessed by the British Medical Research Council grading system at 12 months.
Time frame: 12 months
Moving 2 Point Discrimination test (m2PD) in the target digit at 12 months.
Time frame: 12 months
The summary score from the Disabilities of the Arm Shoulder and Hand (DASH) questionnaire at 12 months.
Time frame: 12 months
The summary score from the Disabilities of the Arm Shoulder and Hand (DASH) Work Module at 12 months.
Time frame: 12 months
The summary score from the Disabilities of the Arm Shoulder and Hand (DASH) Sports/Performing Arts Module 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 26 Jun 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.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NeuroSpan Bridge, NeuroGen Nerve Guide and Nerve Autograft in people with Peripheral Nerve Injuries, run by Auxilium Biotechnologies at 8 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 4 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: looking for participants now, as of the sponsor's last update on 26 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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?
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 Jacob Koffler, PhD, MBA (858-699-9443, j.koffler@auxiliumbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy- Static two-point discrimination (s2PD) measured at 12 months. (time frame: 12 months). The study lists 2 primary outcomes in all. 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 26 Jun 2026.