NTX-001 for Peripheral Nerve Injury

Recruiting at 1 trial location

Overseen By Kristen Olszyk, MS

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Neuraptive Therapeutics Inc.

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 6

98 Participants Needed

Trial Summary

What is the purpose of 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.

Research Team

Seth Schulman, MD

Principal Investigator

Neuraptive Therapeutics Inc.

Eligibility Criteria

This trial is for adults aged 18-80 with severe upper extremity nerve injuries that need surgery. Participants must have a specific type of nerve damage (Sunderland's 4th or 5th degree) and be willing to sign a consent form.

Inclusion Criteria

I have severe nerve damage in my arm that needs surgery.

I have agreed to join this study and signed the consent form.

I am between 18 and 80 years old.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Surgical Treatment

Participants undergo surgical repair of upper extremity peripheral nerve injury using NTX-001 in conjunction with standard suture neurorrhaphy

Intraoperative

1 visit (in-person, in operating room)

Post-operative Monitoring

Participants are monitored for safety and effectiveness of the surgical treatment, including pain assessment and nerve function tests

48 weeks

Regular visits at Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24, 30, 36, 42, and 48

Follow-up

Participants are monitored for long-term safety and effectiveness after the main treatment phase

12 weeks

2 visits (in-person)

Treatment Details

Interventions

• NTX-001

Trial Overview The study tests NTX-001, a one-time surgical product used alongside standard stitching techniques for repairing severed nerves during surgery.

Participant Groups

Group I: NTX-001 Experimental Treatment 1 Intervention

NTX-001 used during the surgical repair of an upper extremity peripheral nerve injury in conjunction with standard suture neurorrhaphy.

Group II: Standard Suture Neurorrhaphy Active Control 1 Intervention

Standard of Care

Who Is Running the Clinical Trial?

Neuraptive Therapeutics Inc.

Lead Sponsor

Trials

5

Recruited

160+