CompletedPhase 2

Safety and Efficacy of NTX-001 Compared to SOC in Acute Single Peripheral Nerve Injuries

United States51 participantsStarted 2020-09-25

Plain-language 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.

Who can participate

Age range

12 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of Participants With Treatment Emergent Adverse Events and Serious Adverse Events

Timeframe: Up to 48 Weeks

Michigan Hand Questionnaire Total Score (MHQ)

Timeframe: Week 12

Trial details

NCT IDNCT04572906

SponsorNeuraptive Therapeutics Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-06-27

View on ClinicalTrials.gov More Peripheral Nerve Injuries trials

Who can participate

Age range

12 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.