This Study Will Evaluate the Effectiveness of NTX-001, a Surgical Nerve Repair Product When Used in People with Upper Extremity Nerve Lacerations.
Purpose
NTX-001 is a single use surgical product intended for use in conjunction with standard suture neurorrhaphy of severed nerves in patients between 18 and 80.
Conditions
- Peripheral Nerve Injury Upper Limb
- Peripheral Nerve Injury (PNI)
Eligibility
- Eligible Ages
- Between 18 Years and 80 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- The subject has voluntarily agreed to participate in this study and has signed an Institutional Review Board (IRB) approved informed consent form. - The subject is between eighteen (18) and eighty (80) years of age. - The subject has clinical evidence of a Sunderland's 4th degree (Class II) or 5th degree (Class III) nerve transection(s) that has resulted in upper extremity nerve impairment that requires surgical treatment.
Exclusion Criteria
- Subjects whose nerve repair will occur greater than 48 hours after nerve transection. - Subjects requiring nerve repair involving an autograft, allograft or conduit(s). - Subjects with multiple transected nerve injuries are allowed into the study only if all injuries are amenable to direct repair. - Subjects who, in the judgement of the investigator, are not likely to demonstrate meaningful recovery within a reasonable time frame during follow up due to significant muscle atrophy or other morbidity. - The subject's injury is a result of a suicide attempt or self- harm. - The subject has documented history or clinical signs of any condition where NTX-001 might not prove beneficial (e.g., systemic neuromuscular disease, systemic neurological deficit, or other treatments known to affect the growth and/or physiology of the neural and vascular system). - The subject has a known allergy to polyethylene glycol (PEG) or human grade silicone. - The subject is pregnant or breastfeeding. - The subject is currently enrolled in another investigational study or has participated in an investigational study within 30 days prior to screening.
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- Treatment vs. Standard of Care
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Outcomes Assessor)
- Masking Description
- All study personnel involved in the surgical procedure will be unblinded. Patient, Care Providers and outcomes evaluators will be blinded.
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental NTX-001 |
NTX-001 used during the surgical repair of an upper extremity peripheral nerve injury in conjunction with standard suture neurorrhaphy. |
|
|
No Intervention Standard Suture Neurorrhaphy |
Standard of Care |
|
Recruiting Locations
Baltimore, Maryland 21218
More Details
- Status
- Recruiting
- Sponsor
- Neuraptive Therapeutics Inc.
Detailed Description
NTX-001 has been developed as a surgical product to be used in conjunction with standard suture neurorrhaphy of a severed nerve. Use of NTX-001 is intended to safely accelerate the often slow and diminished return of function in repaired nerves. It often takes months and/or years to determine if function will be restored. By that point, restoration is often incomplete and can result in lifelong motor and/or sensory deficits. By reconnecting (PEG-fusion) a substantial number of axons within a severed nerve, the degeneration-regeneration cycle and subsequent atrophy may be reduced or even prevented for those axons and their targets, respectively. NTX-001 (PEG-fusion) has the potential to avoid the consequences of protracted denervation of distal target tissues by eliminating the period of total denervation thus reducing the time to stable recovery and providing greater innervation to affected tissues.