New treatment option for Peripheral Nerve Injuries
Official title A Comparison of NeuroSpan Bridge, NeuraGen Nerve Guide, and Nerve Autograft for Peripheral Nerve Repair
ClinicalTrials.gov ID: NCT06529835
What this study is testing
- What it's testing
- This is a multicenter, prospective, randomized, subject and evaluator blinded clinical trial to asses the efficacy of Auxilium's NeuroSpan Bridge.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- 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
You likely can't join if
- 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...
- Allergy to Bovine products such as Bovine Collagen Nerve Cuff.
- Pregnancy or planning to become pregnant
See the full eligibility criteria
- 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)
- 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
The study team makes the final eligibility decision.
Where it's taking place
- San Diego, California, United States
- San Francisco, California, United States
- Baltimore, Maryland, United States
- New York, New York, United States
- Columbus, Ohio, United States
- Philadelphia, Pennsylvania, United States
- Houston, Texas, United States
- San Antonio, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include San Diego, California, United States; San Francisco, California, United States; Baltimore, Maryland, United States; New York, New York, United States; Columbus, Ohio, United States; Philadelphia, Pennsylvania, United States and 2 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.