NTX-001 for Upper Extremity Nerve Lacerations
This study is evaluating NTX-001, a surgical product designed to help repair severed nerves in the arm or hand. NTX-001 is applied during surgery along with standard nerve repair techniques. It aims to speed up nerve recovery and improve function by reconnecting nerve fibers. You may be able to join if you are between 18 and 80 years old and have a severe nerve injury in your arm or hand. Researchers will measure success by looking at how your hand function and pain change over 24 weeks using a questionnaire. The study is planning to enroll 98 people, but its current status is unclear.
- Study design
- This interventional study plans to enroll 98 participants. The specific phase of the study is not mentioned.
- What's involved
- You would have a screening visit, and then follow-up visits at weeks 4, 12, 24, and 48. During these visits, your hand function and pain levels will be assessed.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for safety assessments up to 48 weeks after the intervention.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
This Study Will Evaluate the Effectiveness of NTX-001, a Surgical Nerve Repair Product When Used in People With Upper Extremity Nerve Lacerations.
At a glance
Conditions
NCT06616025
Where you'd take part
This study runs at 24 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Allegheny Health Network
Pittsburgh, Pennsylvaniastudy coordinator listed
Recruiting
Barnes-Jewish Hospital 1 Barnes Jewish Hospital Plaza St.
St Louis, Missouristudy coordinator listed
Recruiting
Baylor, Scott and White Health
Dallas, Texasstudy coordinator listed
Recruiting
Cedars Sinai Medical Center
Los Angeles, Californiastudy coordinator listed
Not yet recruiting
Curtis National Center at MedStar Union Memorial Hospital
Baltimore, Marylandstudy coordinator listed
Recruiting
Grady Health
Atlanta, Georgiastudy coordinator listed
Recruiting
Harborview Medical Center
Seattle, Washingtonstudy coordinator listed
Recruiting
Louisiana State University Health Sciences Center
New Orleans, Louisianastudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Seth Schulman, MD · STUDY_DIRECTOR · Neuraptive Therapeutics Inc.
Who to contact
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Inclusion
Exclusion
What this trial measures
- Mean Michigan Hand Questionnaire (MHQ) Two Domain Score (ADL and Pain)Screening Visit, Week 24
The subject will complete the MHQ questionnaire at Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24, 30, 36, 42, and 48. A measure of the mean of MHQ in the Two Domains, Activities of Daily Living and Pain Scores, at Week 24 in the NTX-001 group as compared to Standard of Care (SoC). In the ADL subdomain, a higher component score indicates better function. In the Pain subdomain, a higher component score indicates greater pain. A total MHQ score of 100 is considered the best functional score.
- Safety - Columbia-Suicide Severity Rating ScaleScreening Visit, Weeks 4, 12, and 48
The Columbia-Suicide Severity Rating Scale (C-SSRS) is a suicide risk assessment tool. The C-SSRS tool asks; whether and when the subject has had a thought about suicide (ideation); what actions they might have taken and what they did to prepare for suicide; whether and when they attempted suicide or began a suicide attempt that was either interrupted by another person or stopped of their own volition. The answers identify whether someone is at risk for suicide, assessing the severity and immediacy of that risk, and gauging the level of support that the person needs. The first assessment is done by study staff at screening. Subsequent assessments will be completed by the subject at Weeks 4, 12, and 48. A score of 0 indicates no risk, 1-2 indicates low risk, and 3+ indicates moderate to high risk.