This Study Will Evaluate the Effectiveness of NTX-001, a Surgical Nerve Repair Product When Used in People With Upper Extremity Nerve Lacerations. (NCT06616025)
Phase 3, Multicenter, Randomized, Subject and Evaluator Blinded, Controlled Study Evaluating the Safety and Efficacy of NTX-001 Compared to Standard of Care (Neurorrhaphy) in the Treatment of Upper Extremity Transected Nerves Requiring Surgical Repair.
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Cedars Sinai Medical Center — Los Angeles, California
Age range: 18 Years to 80 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (24 Sites)
- Cedars Sinai Medical Center — Los Angeles, California
- Rothman Orthopedics - Advent Health — Orlando, Florida
- Orlando Health Orlando Regional Medical Center — Orlando, Florida
- Grady Health — Atlanta, Georgia
- University of Chicago — Chicago, Illinois
- University of Louisville — Louisville, Kentucky
- Louisiana State University Health Sciences Center — New Orleans, Louisiana
- Curtis National Center at MedStar Union Memorial Hospital — Baltimore, Maryland
- Missouri Orthopaedic Institute — Columbia, Missouri
- Barnes-Jewish Hospital 1 Barnes Jewish Hospital Plaza St. — St Louis, Missouri
- The Cooper Health System — Camden, New Jersey
- NYU Langone Health — New York, New York
- UC Health — Cincinnati, Ohio
- University of Cincinnati Health — Cincinnati, Ohio
- The MetroHealth System — Cleveland, Ohio
- The Ohio State University Wexner Medical Center — Columbus, Ohio
- University of Pennsylvania, Department of Orthopaedic Surgery — Philadelphia, Pennsylvania
- Allegheny Health Network — Pittsburgh, Pennsylvania
- Medical University of South Carolina — Charleston, South Carolina
- Baylor, Scott and White Health — Dallas, Texas
- Texas Tech — Lubbock, Texas
- University of Utah Health — Salt Lake City, Utah
- UVA Health — Charlottesville, Virginia
- Harborview Medical Center — Seattle, Washington
📞 Contact the Study Coordinator
Phone: (215) 206-9504
Email: seth.schulman@neuraptive.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
Explore by condition: All Peripheral Nerve Injury Upper Limb clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.