Peripheral Nerve Injuries
Conditions
Brief summary
NTX-001 is a single use surgical product intended for use in conjunction with standard suture neurorrhaphy of severed nerves in patients between 16 and 80 years of age.
Detailed description
NTX-001 (Product) is a surgical product that consists of an active solution (drug), an isolation chamber medical device (chamber or device) and two (2) other sterile solutions. 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.
Interventions
COMBINATION_PRODUCTNTX-001
One time use surgical product, 3 solutions applied topically, in sequence, to the peripheral nerve repair site, in conjunction with standard suture neurorrhaphy. An isolation chamber medical device (device) is utilized to focus the application of PEG (Solution #2) on the coapted nerve for the required amount of exposure time.
Sponsors
Neuraptive Therapeutics Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Masking description
All study personnel involved in the surgical procedure will be unblinded. Patient and outcomes evaluators will be blinded.
Intervention model description
Treatment vs. Standard of Care
Eligibility
Sex/Gender
ALL
Age
12 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* The subject is at least 12 years of age and not older than 80. * The subject has sustained a confirmed (intra-op assessment) single transected peripheral nerve injury. * The subject's nerve injury is classified as Sunderland's Fourth and Fifth Degree (Class III) * The subject's nerve injury is amenable to minimal or acceptable tension, in direct, end-to-end repair. * The surgical repair will occur within 48 hours of injury.
Exclusion criteria
* The subject has a PNI with a segmental loss (gap) that cannot be repaired with minimal or acceptable tension. * Other treatments known to affect the growth and/or physiology of the neural and vascular system. * The nerve injury has vascular damage that cannot be repaired to provide adequate perfusion of the injured site. * The subject is pregnant and/or is breastfeeding. * The subject has a significant medical comorbidity precluding immediate repair.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Treatment Emergent Adverse Events and Serious Adverse Events | Up to 48 Weeks | An adverse event is any untoward, undesired, or unplanned event in the form of signs, symptoms, disease, or laboratory or physiologic observations occurring in a person given a study product or in a clinical study. A treatment-emergent adverse event was defined as any adverse event that newly appeared, increased in frequency, or worsened in severity on or after the exposure to the study product. |
| Michigan Hand Questionnaire Total Score (MHQ) | Week 12 | The MHQ measures hand function and is scored from 0-100; with 100 being the best score. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Modified British Medical Research Council (MMRC) motor grading (M0-M5) | Weeks 4, 8, 12, 24, 36 and 48 | The MRCC motor measures the function of the muscles; on a scale from M0 to M5; the higher score indicates better strength. |
| Semmes-Weinstein Monofilament Test (SWMT) | Weeks 4, 8, 12, 24, 36 and 48 | The SWMT assesses sensation using using equipment that measures force felt in grams. |
| Pinch Strength | Weeks 4, 8, 12, 24, 36 and 48 | The Pinch test assesses strength using using equipment that measures strength in pounds. |
| Numeric Pain Rating Scale (NPRS) | Weeks 4, 8, 12, 24, 36 and 48 | The NPRS measures pain intensity on a scale from 0 representing no pain and 10 to the worst pain as bad as you can imagine. |
| Cold Intolerance Symptom Severity (CISS) | Weeks 4, 8, 12, 24 and 48 | The CISS focuses on the impact of cold intolerance on activities of daily life; the score ranges a score between 0 and 10, where 0 is no symptoms at all and 100 is the most severe symptoms you can possibly imagine. |
| Patient Global Impression of Change (PGIC) | Weeks 4, 8, 12, 24 and 48 | The PGIC measures information about the effect of a treatment intervention in an individual subject, scored 0 to 7; with 0 being the worst and 7 being the best. |
| Grip Strength | Weeks 4, 8, 12, 24, 36 and 48 | The Grip test assesses strength using using equipment that measures strength in pounds. |
| Modified British Medical Research Council (MMRC) sensory grading (S0-S4) | Weeks 4, 8, 12, 24, 36 and 48 | The SWMT measures sensation as using a score from S0 to S4; higher score indicates better sensation. |
Countries
United States
Outcome results
None listed