NTX-001 to Repair Peripheral Nerve Transection(s)

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

• Registration Number: NCT05565846
• Lead Sponsor: Neuraptive Therapeutics Inc.

Brief Summary

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

Detailed Description

For this expanded access program, there is a case-by-case internal review process conducted by Neuraptive after the respective investigator provides a prospective case narrative for enrollment consideration.

Allowed Sunderland Classifications are IV degree (Seddon's Class II) and V degree (Seddon's Class III). If the case is approved, the investigator can move forward.

Patients who are between twelve (12) and eighty (80) years of age and has clinical evidence of a peripheral nerve transection from conditions or interventions that has or may result in motor and/or sensory impairment and require surgical treatment. All peripheral nerve repairs including gap repairs (autografts) will be considered for enrollment.

Study Timeline

• Study First Submitted: 2022-07-21
• Study First Submitted QC: 2022-09-28
• Study First Posted: 2022-10-04
• Status Verified: 2024-06
• Last Update Submitted: 2025-05-19
• Last Update Posted: 2025-05-22

Recruitment & Eligibility

• Status: AVAILABLE
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: EXPANDED_ACCESS
• Study Design: Not specified

Trial Locations

Locations (2)

Harborview Medical Center; 🇺🇸 Seattle, Washington, United States

Orlando Health Orthopedic Institute; 🇺🇸 Orlando, Florida, United States