NTX-001 to Repair Peripheral Nerve Transection(s)

NCT05565846 | Unknown

• 1 other identifier: EA-NTX-22-002
• Study Type: expanded_access
• Target: N/A
• Locations: 1 country
• Sites: 2

Brief Summary

The proposed use of NTX-001 for transections of upper extremity and facial peripheral nerves, acutely or planned.

Conditions

Peripheral Nerve Transections, Acute or Planned in Upper Extremity and Facial Nerves

Interventions

NTX-001 COMBINATION_PRODUCT

One-time use surgical product of three solutions and a device

Eligibility Criteria

• Age: 12 Years - 80 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• \. The patient has clinical evidence of a peripheral nerve transection from conditions or interventions that has or may result in motor and/or sensory impairment and requires surgical treatment.

You may not qualify if:

• Patients whose nerve repair will occur greater than 48 hours after nerve transection.
• Patients requiring repair of the intracranial portion of any nerve.
• Patients requiring a nerve repair involving an allograft or conduit.
• Patients expected to show signs of spontaneous recovery by 12 months (e.g., Bell's palsy).
• Patients 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 patient 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 patient has a known allergy to polyethylene glycol (PEG) or human grade silicone.

Sponsors & Collaborators

• Neuraptive Therapeutics Inc.: lead

Study Sites (2)

Orlando Health Orthopedic Institute

Orlando, Florida, 32806, United States

AVAILABLE

Harborview Medical Center

Seattle, Washington, 98104, United States

AVAILABLE

Central Study Contacts

Seth Schulman, MD

CONTACT

617-416-4520; seth.schulman@neuraptive.com

Anna Dodds, BS

CONTACT

724-991-4431; anna.dodds@neuraptive.com

Study Design

• Study Type: expanded access
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2022
• First Posted: October 4, 2022
• Last Updated: May 22, 2025

Record last verified: 2024-06

Locations

US (2)