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RecruitingPhase 3

This Study Will Evaluate the Effectiveness of NTX-001, a Surgical Nerve Repair Product When Used in People With Upper Extremity Nerve Lacerations.

Neuraptive Therapeutics Inc. · NCT06616025

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18–80 · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 3
Target enrollment
98
US sites recruiting
23
Study start
February 10, 2025
Record last updated
October 6, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: NTX-001 (PEG-Fusion)

Conditions: Peripheral Nerve Injury Upper Limb; Peripheral Nerve Injury (PNI)

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

Inclusion 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.

Exclusion Criteria

  • Subjects whose nerve repair will occur greater than 48 hours after nerve transection.
  • Subjects requiring nerve repair involving an autograft, allograft or conduit(s).
  • Subjects with multiple transected nerve injuries are allowed into the study only if all injuries are amenable to direct repair.
  • Subjects 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 growth and/or physiology of the neural and vascular system).
  • 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.

Recruiting US locations

  • Rothman Orthopedics - Advent Health

    Orlando, FL 32804

    Site contact: Amir Reza Kachooei, MD PhD · 844-407-4070 · amir.kachooei@rothmanortho.com

  • Orlando Health Orlando Regional Medical Center

    Orlando, FL 32806

    Site contact: Justin Zumsteg, MD · 321-843-5851 · Justin.Zumsteg@orlandohealth.com

  • Grady Health

    Atlanta, GA 30303

    Site contact: Nicole A Zelenski, MD · 404-251-1566 · nicole.ann.zelenski@emory.edu

  • University of Chicago

    Chicago, IL 60637

    Site contact: Jeffrey Stepan, MD MSc · 773-702-0494 · jstepan@bsd.uchicago.edu

  • University of Louisville

    Louisville, KY 40202

    Site contact: Tuna Ozyurekoglu, MD · 502-562-0352 · tuna.ozyurekoglu@louisville.edu

  • Louisiana State University Health Sciences Center

    New Orleans, LA 70112

    Site contact: Harvey Chim,, MD · (504) 568-4750 · hchim@lsuhsc.edu

  • Curtis National Center at MedStar Union Memorial Hospital

    Baltimore, MD 21218

    Site contact: Kenneth R Means Jr., MD · 410-554-2486 · kennethrmeans@curtishand.com

  • Missouri Orthopaedic Institute

    Columbia, MO 65211

    Site contact: Julia Nuelle, MD · 573-882-2663 · julia.nuelle@health.missouri.edu

  • Barnes-Jewish Hospital 1 Barnes Jewish Hospital Plaza St.

    St Louis, MO 63110

    Site contact: David M Brogan, MD, MSc · 314-747-2813 · brogand@wustl.edu

  • The Cooper Health System

    Camden, NJ 08103

    Site contact: David A Fuller, MD · 856-968-7262 · Fuller-David@CooperHealth.edu

  • NYU Langone Health

    New York, NY 10003

    Site contact: Jacques Hacquebord, MD · 212-263-7582 · Jacques.hacquebord@nyulangone.org

  • UC Health

    Cincinnati, OH 45267

    Site contact: Sonu Jain, MD, FACS · 513-558-2765 · sonu.jain@uc.edu

  • University of Cincinnati Health

    Cincinnati, OH 45267

    Site contact: Sonu Jain, MD · 504-296-8215 · jain3su@ucmail.uc.edu

  • The MetroHealth System

    Cleveland, OH 44109

    Site contact: Kyle J Chepla, MD · 216-778-7878 · kchepla@metrohealth.org

  • The Ohio State University Wexner Medical Center

    Columbus, OH 43212

    Site contact: Ryan Schmucker, MD · 614-293-8566 · Ryan.Schmucker@osumc.edu

  • University of Pennsylvania, Department of Orthopaedic Surgery

    Philadelphia, PA 19104

    Site contact: Ines C Lin, MD · 215-662-7300 · ines.lin@uphs.upenn.edu

  • Allegheny Health Network

    Pittsburgh, PA 15212

    Site contact: Steven Regal, MD · 877-660-6777 · Steven.REGAL@ahn.org

  • Medical University of South Carolina

    Charleston, SC 29429

    Site contact: Charles A Daly, MD · 843-876-2211 · dalyc@musc.edu

  • Baylor, Scott and White Health

    Dallas, TX 75246

    Site contact: Asadullah Helal, MD · 469-800-7200 · Asadullah.Helal@BSWHealth.org

  • Texas Tech

    Lubbock, TX 79415

    Site contact: Brendan J MacKay, MD · 806-743-2584 · brendan.j.mackay@ttuhsc.edu

  • University of Utah Health

    Salt Lake City, UT 84132

    Site contact: Mark A Mahan, MD, FAANS · 801-585-7917 · mark.mahan@hsc.utah.edu

  • UVA Health

    Charlottesville, VA 22903

    Site contact: Brett DeGeorge, MD · 434-924-5078 · bd6u@virginia.edu

  • Harborview Medical Center

    Seattle, WA 98104

    Site contact: Yusha ( Katie) Liu, MD PhD · 206-744-3000 · HMCnerve@uw.edu

Study contacts (from the official record)

  • Seth Schulman, MD · 215-206-9504 · seth.schulman@neuraptive.com
  • Kristen Olszyk, MS · 484-753-1205 · kristen.olszyk@neuraptive.com
This Study Will Evaluate the Effectiveness of NTX-001, a Surgical… (NCT06616025) | Bored Studies