Peripheral Nerve Injury Upper Limb study: NTX-001
Official title This Study Will Evaluate the Effectiveness of NTX-001, a Surgical Nerve Repair Product When Used in People With Upper Extremity Nerve Lacerations.
ClinicalTrials.gov ID: NCT06616025
What this study is testing
What is NTX-001 (PEG-Fusion)?
An investigational once‑use surgical product being studied to help repair severed peripheral nerves in the upper limb. is designed to apply three topical solutions to the nerve repair site to promote axon reconnection.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study aims to determine whether NTX‑001 improves nerve healing when added to standard surgical repair.
- Who it's for
- Adults aged 18 to 80 who have a severed nerve in an arm or hand.
- What's involved
- Participants will receive the NTX‑001 product during their nerve‑repair surgery, which is a one‑time use device applied while suturing the nerve.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- The subject has voluntarily agreed to participate in this study and has signed an Institutional Review Board (IRB) approved informed consent form.
- The subject is between eighteen (18) and eighty (80) years of age.
- The subject has clinical evidence of a Sunderland's 4th degree (Class II) or 5th degree (Class III) nerve transection(s) that has resulted in upper...
You likely can't join if
- people whose nerve repair will occur greater than 48 hours after nerve transection.
- people requiring nerve repair involving an autograft, allograft or conduit(s).
- people with multiple transected nerve injuries are allowed into the study only if all injuries are amenable to direct repair.
- people who, in the judgement of the investigator, are not likely to demonstrate meaningful recovery within a reasonable time frame during follow up...
- The subject's injury is a result of a suicide attempt or self- harm.
- The subject has documented history or clinical signs of any condition where NTX-001 might not prove beneficial (e.g., systemic neuromuscular disease...
See the full eligibility criteria
- The subject has voluntarily agreed to participate in this study and has signed an Institutional Review Board (IRB) approved informed consent form.
- The subject is between eighteen (18) and eighty (80) years of age.
- The subject has clinical evidence of a Sunderland's 4th degree (Class II) or 5th degree (Class III) nerve transection(s) that has resulted in upper extremity nerve impairment that requires surgical treatment.
- people whose nerve repair will occur greater than 48 hours after nerve transection.
- people requiring nerve repair involving an autograft, allograft or conduit(s).
- people with multiple transected nerve injuries are allowed into the study only if all injuries are amenable to direct repair.
- people 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 subject's injury is a result of a suicide attempt or self- harm.
- The subject 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 subject has a known allergy to polyethylene glycol (PEG) or human grade silicone.
- The subject is pregnant or breastfeeding.
- The subject is currently enrolled in another investigational study or has participated in an investigational study within 30 days prior to screening.
The study team makes the final eligibility decision.
Where it is enrolling
- Orlando, Florida, United States
- Atlanta, Georgia, United States
- Chicago, Illinois, United States
- Louisville, Kentucky, United States
- New Orleans, Louisiana, United States
- Baltimore, Maryland, United States
- Columbia, Missouri, United States
- St Louis, Missouri, United States
- Camden, New Jersey, United States
- New York, New York, United States
- Cincinnati, Ohio, United States
- Cleveland, Ohio, United States
- Columbus, Ohio, United States
- Philadelphia, Pennsylvania, United States
- Pittsburgh, Pennsylvania, United States
- Charleston, South Carolina, United States
- Dallas, Texas, United States
- Lubbock, Texas, United States
- Salt Lake City, Utah, United States
- Charlottesville, Virginia, United States
+ 1 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Orlando, Florida, United States; Atlanta, Georgia, United States; Chicago, Illinois, United States; Louisville, Kentucky, United States; New Orleans, Louisiana, United States; Baltimore, Maryland, United States and 15 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.