NCT05565846

NTX-001 to Repair Peripheral Nerve Transection(s)

An Open-Label Study Using NTX-001 to Repair Peripheral Nerve Transection(s)

• Status: Available
• Phase: —
• Study type: Expanded Access
• Enrollment: —
• Sponsor: Neuraptive Therapeutics Inc. · Industry
• Sex: All
• Age: 12 Years – 80 Years
• Healthy volunteers: —

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.

Conditions

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

Interventions

Type	Name	Description
COMBINATION_PRODUCT	NTX-001	One-time use surgical product of three solutions and a device

Timeline

• First posted: 2022-10-04
• Last updated: 2025-05-22

Locations

2 sites across 1 country: United States