Recruiting

Phase 3

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

Sponsor:

Neuraptive Therapeutics Inc.

Code:

NCT06616025

Conditions

Peripheral Nerve Injury Upper Limb

Peripheral Nerve Injury (PNI)

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

NTX-001 (PEG-Fusion)

Study Details

Brief summary:

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.

Conditions

Peripheral Nerve Injury Upper Limb

Peripheral Nerve Injury (PNI)

Study ID

NCT06616025

Start date

Feb 10, 2025

Status verified date

May, 2026

Completion date

Apr 30, 2027

Anticipated

Primary completion date

Mar 31, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

98 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: NTX-001

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

no intervention: Standard Suture Neurorrhaphy

Standard of Care

Interventions

NTX-001 (PEG-Fusion)

One time use surgical product, 3 solutions applied topically, in sequence, to the peripheral nerve repair site, in conjunction with standard suture neurorrhaphy.

Primary outcome measure

Mean Michigan Hand Questionnaire (MHQ) Two Domain Score (ADL and Pain) [ Time Frame: Screening Visit, Week 24 ]
Safety - Columbia-Suicide Severity Rating Scale [ Time Frame: Screening Visit, Weeks 4, 12, and 48 ]

Central Contacts and Locations

Central contacts

Seth Schulman, MD

215-206-9504 seth.schulman@neuraptive.com

Kristen Olszyk, MS

484-753-1205 kristen.olszyk@neuraptive.com

Locations

Rothman Orthopedics - Advent Health

Recruiting

Orlando, Florida, United States, 32804

Contacts

Amir Reza Kachooei, MD PhD

844-407-4070 amir.kachooei@rothmanortho.com

Rosemary Vargas, Coordinator

407-752-5452 Rosemary.Vargas@AdventHealth.com

Principal Investigator:

Amir Reza Kachooei, MD PhD

Orlando Health Orlando Regional Medical Center

Recruiting

Orlando, Florida, United States, 32806

Contacts

Justin Zumsteg, MD

321-843-5851 Justin.Zumsteg@orlandohealth.com

Carlis Rodriguez-Saavedra

321-841-3631 Carlis.RodriguezSaavedra@orlandohealth.com

Principal Investigator:

Justin Zumsteg, MD

Grady Health

Recruiting

Atlanta, Georgia, United States, 30303

Contacts

Nicole A Zelenski, MD

404-251-1566 nicole.ann.zelenski@emory.edu

Morgan Fuller, MS

404-251-8953 mrfulle@emory.edu

Principal Investigator:

Nicole A Zelenski, MD

University of Chicago

Recruiting

Chicago, Illinois, United States, 60637

Contacts

Jeffrey Stepan, MD MSc

773-702-0494 jstepan@bsd.uchicago.edu

Michael Koch

773-834-0822 mkoch@bsd.uchicago.edu

Principal Investigator:

Jeffrey Stepan, MD

University of Louisville

Recruiting

Louisville, Kentucky, United States, 40202

Contacts

Tuna Ozyurekoglu, MD

502-562-0352 tuna.ozyurekoglu@louisville.edu

Anne Jerde, Lead Coordinator

502-852-5251 ann.jerde@louisville.edu

Principal Investigator:

Tuna Ozyurekoglu, MD

Louisiana State University Health Sciences Center

Recruiting

New Orleans, Louisiana, United States, 70112

Contacts

Harvey Chim,, MD

(504) 568-4750 hchim@lsuhsc.edu

Tanja Milosavljevic, MSc, PhD

504-568-6876 tmilos@lsuhsc.edu

Principal Investigator:

Harvey Chim, MD, FACS

Curtis National Center at MedStar Union Memorial Hospital

Recruiting

Baltimore, Maryland, United States, 21218

Contacts

Kenneth R Means Jr., MD

410-554-2486 kennethrmeans@curtishand.com

Ike Fleming, Research Program Manager

410-554-2486 Ike.C.Fleming@medstar.net

Principal Investigator:

Kenneth R Means Jr., MD

Missouri Orthopaedic Institute

Recruiting

Columbia, Missouri, United States, 65211

Contacts

Julia Nuelle, MD

573-882-2663 julia.nuelle@health.missouri.edu

Bryce Fletcher

573-884-1248 brycefletcher@health.missouri.edu

Principal Investigator:

Julia Nuelle, MD

Barnes-Jewish Hospital 1 Barnes Jewish Hospital Plaza St.

Recruiting

St Louis, Missouri, United States, 63110

Contacts

David M Brogan, MD, MSc

314-747-2813 brogand@wustl.edu

Michelle Moore, Clinical Research Coordinator

314-273-2403 michellemoore@wustl.edu

Principal Investigator:

David M Brogan, MD, MSc

The Cooper Health System

Recruiting

Camden, New Jersey, United States, 08103

Contacts

David A Fuller, MD

856-968-7262 Fuller-David@CooperHealth.edu

Pietro M Gentile, Manager of Research Division

856-213-0094 gentile-pietro@CooperHealth.edu

Principal Investigator:

David A Fuller, MD

NYU Langone Health

Recruiting

New York, New York, United States, 10003

Contacts

Jacques Hacquebord, MD

212-263-7582 Jacques.hacquebord@nyulangone.org

Anne Genzelev

212-263-7582 Anne.Genzelev@nyulangone.org

Principal Investigator:

Jacques Hacquebord, MD

UC Health

Recruiting

Cincinnati, Ohio, United States, 45267

Contacts

Sonu Jain, MD, FACS

513-558-2765 sonu.jain@uc.edu

Brittany Rowley, CCRC Clinical Research Professional III

513-558-2765 rowleybm@ucmail.uc.edu

Principal Investigator:

Sonu Jain, MD

University of Cincinnati Health

Recruiting

Cincinnati, Ohio, United States, 45267

Contacts

Sonu Jain, MD

504-296-8215 jain3su@ucmail.uc.edu

Brittany Rowley, Lead Coordinator

513-558-2765 rowleybm@ucmail.uc.edu

Principal Investigator:

Sonu Jain, MD

The MetroHealth System

Recruiting

Cleveland, Ohio, United States, 44109

Contacts

Kyle J Chepla, MD

216-778-7878 kchepla@metrohealth.org

Hannah Amiott, Clinical Research Coordinator

216-778-1163 HAmiott@metrohealth.org

Principal Investigator:

Kyle Chepla, MD

The Ohio State University Wexner Medical Center

Recruiting

Columbus, Ohio, United States, 43212

Contacts

Ryan Schmucker, MD

614-293-8566 Ryan.Schmucker@osumc.edu

Emily Rice

614-293-5871 Emily.Rice2@osumc.edu

Principal Investigator:

Ryan Schmucker, MD

University of Pennsylvania, Department of Orthopaedic Surgery

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Ines C Lin, MD

215-662-7300 ines.lin@uphs.upenn.edu

Annamarie D. Horan, MPA, PhD

215-847-0132 horana@pennmedicine.upenn.edu

Principal Investigator:

Ines C Lin, MD

Allegheny Health Network

Recruiting

Pittsburgh, Pennsylvania, United States, 15212

Contacts

Steven Regal, MD

877-660-6777 Steven.REGAL@ahn.org

Mary Fetter - Lead Clinical Research Coordinator

412-359-8292 Mary.Fetter@ahn.org

Principal Investigator:

Steven Regal, MD

Medical University of South Carolina

Recruiting

Charleston, South Carolina, United States, 29429

Contacts

Charles A Daly, MD

843-876-2211 dalyc@musc.edu

Lisa Mock

843-876-2211 mockl@musc.edu

Principal Investigator:

Charles Daly, MD

Baylor, Scott and White Health

Recruiting

Dallas, Texas, United States, 75246

Contacts

Asadullah Helal, MD

469-800-7200 Asadullah.Helal@BSWHealth.org

Angela Young Young - Clinical Research Coordinator

214-820-4787 Angela.Young1@BSWHealth.org

Principal Investigator:

Asadullah Helal, MD

Texas Tech

Recruiting

Lubbock, Texas, United States, 79415

Contacts

Brendan J MacKay, MD

806-743-2584 brendan.j.mackay@ttuhsc.edu

Evan J Hernandez, Clinical Researcher - MBA

806-743-6846 evan.j.hernandez@ttuhsc.edu

Principal Investigator:

Brendan MacKay, MD

UVA Health

Recruiting

Charlottesville, Virginia, United States, 22903

Contacts

Brett DeGeorge, MD

434-924-5078 bd6u@virginia.edu

Milos Lesevic, MD

434-924-2549 ML4EC@uvahealth.org

Principal Investigator:

Brett DeGeorge, MD

Harborview Medical Center

Recruiting

Seattle, Washington, United States, 98104

Contacts

Yusha ( Katie) Liu, MD PhD

206-744-3000 HMCnerve@uw.edu

Laura Hennessy, RN

206-744-7723 hennessy@uw.edu

Principal Investigator:

Katie Liu, MD

More Information

Sponsor

Neuraptive Therapeutics Inc.

Last update posted

Jul 31, 2026

Last verified

May, 2026

Keywords

Transected Nerves
Requiring Surgical Repair
Upper Extremity

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Neuraptive Therapeutics Inc. on 2026-07-31.