No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 80
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
98 (estimated)
Sponsor
Neuraptive Therapeutics Inc. · Industry
Who this trial is looking for
This trial is looking for adults aged 18 to 80 with severe nerve injuries in the upper arm or hand that need surgery. Participants will receive a surgical product called NTX-001 as part of their nerve repair treatment.
Are You a Good Fit for This Trial?
You may be able to join if
I agree to participate in this study and sign the consent form.
I am between 18 and 80 years old.
I have a severe nerve injury that requires surgery.
You may not be able to join if
My nerve repair will be done more than 48 hours after the injury.
I need a nerve repair using another person’s tissue or a graft.
I have multiple nerve injuries that cannot all be directly repaired.
My doctor thinks I won't recover well from the injury.
My injury is due to a suicide attempt or self-harm.
I have a known allergy to polyethylene glycol (PEG) or silicone.
I am pregnant or breastfeeding.
I am currently in another clinical study or have been in one in the last 30 days.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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.
Trial Locations
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City
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Status
Eligibility Criteria
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 deg…
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.
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