NTX-001 for Nerve Repair in Upper Limb Injuries

This Study Will Evaluate the Effectiveness of NTX-001, a Surgical Nerve Repair Product When Used in People With Upper Extremity Nerve Lacerations.

Recruiting Phase 3 Interventional Study
Peripheral Nerve Injury Upper Limb Peripheral Nerve Injury (PNI)
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.

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About This Trial

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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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…
Contacts

Seth Schulman, MD

215-206-9504

seth.schulman@neuraptive.com

CONTACT

Kristen Olszyk, MS

484-753-1205

kristen.olszyk@neuraptive.com

CONTACT