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

Part of paid clinical trials in Los Angeles, California.

Sponsor: Neuraptive Therapeutics Inc.
Study ID: NCT06616025
Phase: PHASE3
Status: Recruiting

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Conditions

Peripheral Nerve Injury (PNI)
Peripheral Nerve Injury Upper Limb

Eligibility Criteria

Sex: ALL
Age: 18 Years - 80 Years
Healthy Volunteers: Not accepted

Interventions

NTX-001 (PEG-Fusion) — COMBINATION_PRODUCT
One time use surgical product, 3 solutions applied topically, in sequence, to the peripheral nerve repair site, in conjunction with standard suture neurorrhaphy.

Study Details

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.

Key Dates

First listed: Sep 27, 2024
Start date: Feb 10, 2025
Status verified: May 2026
Primary completion: Mar 31, 2027
Completion: Apr 30, 2027

Study Design

Enrollment: 98 participants (estimated)
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Primary Outcome Measure

Mean Michigan Hand Questionnaire (MHQ) Two Domain Score (ADL and Pain) [ Time Frame: Screening Visit, Week 24 ]

Central Contacts

Seth Schulman, MD
215-206-9504
[email protected]
Kristen Olszyk, MS
484-753-1205
[email protected]

Locations (24)

Facility	City	State	ZIP	Site coordinators
Cedars Sinai Medical Center	Los Angeles	California	90048	Meghan C McCullough, MD [email protected] 703-371-9220 Michael Fernandez, Clinical Research Coordinator [email protected] 310-423-0201 Meghan C McCullough, MD (PRINCIPAL_INVESTIGATOR)
Orlando Health Orlando Regional Medical Center	Orlando	Florida	32806	Justin Zumsteg, MD [email protected] 321-843-5851 Carlis Rodriguez-Saavedra [email protected] 321-841-3631 Justin Zumsteg, MD (PRINCIPAL_INVESTIGATOR)
Rothman Orthopedics - Advent Health	Orlando	Florida	32804	Amir Reza Kachooei, MD PhD [email protected] 844-407-4070 Rosemary Vargas, Coordinator [email protected] 407-752-5452 Amir Reza Kachooei, MD PhD (PRINCIPAL_INVESTIGATOR)
Grady Health	Atlanta	Georgia	30303	Nicole A Zelenski, MD [email protected] 404-251-1566 Morgan Fuller, MS [email protected] 404-251-8953 Nicole A Zelenski, MD (PRINCIPAL_INVESTIGATOR)
University of Chicago	Chicago	Illinois	60637	Jeffrey Stepan, MD MSc [email protected] 773-702-0494 Michael Koch [email protected] 773-834-0822 Jeffrey Stepan, MD (PRINCIPAL_INVESTIGATOR)
University of Louisville	Louisville	Kentucky	40202	Tuna Ozyurekoglu, MD [email protected] 502-562-0352 Anne Jerde, Lead Coordinator [email protected] 502-852-5251 Tuna Ozyurekoglu, MD (PRINCIPAL_INVESTIGATOR)
Louisiana State University Health Sciences Center	New Orleans	Louisiana	70112	Harvey Chim,, MD [email protected] (504) 568-4750 Tanja Milosavljevic, MSc, PhD [email protected] 504-568-6876 Harvey Chim, MD, FACS (PRINCIPAL_INVESTIGATOR)
Curtis National Center at MedStar Union Memorial Hospital	Baltimore	Maryland	21218	Kenneth R Means Jr., MD [email protected] 410-554-2486 Ike Fleming, Research Program Manager [email protected] 410-554-2486 Kenneth R Means Jr., MD (PRINCIPAL_INVESTIGATOR)
Missouri Orthopaedic Institute	Columbia	Missouri	65211	Julia Nuelle, MD [email protected] 573-882-2663 Bryce Fletcher [email protected] 573-884-1248 Julia Nuelle, MD (PRINCIPAL_INVESTIGATOR)
Barnes-Jewish Hospital 1 Barnes Jewish Hospital Plaza St.	St Louis	Missouri	63110	David M Brogan, MD, MSc [email protected] 314-747-2813 Michelle Moore, Clinical Research Coordinator [email protected] 314-273-2403 David M Brogan, MD, MSc (PRINCIPAL_INVESTIGATOR)
The Cooper Health System	Camden	New Jersey	08103	David A Fuller, MD [email protected] 856-968-7262 Pietro M Gentile, Manager of Research Division [email protected] 856-213-0094 David A Fuller, MD (PRINCIPAL_INVESTIGATOR)
NYU Langone Health	New York	New York	10003	Jacques Hacquebord, MD [email protected] 212-263-7582 Anne Genzelev [email protected] 212-263-7582 Jacques Hacquebord, MD (PRINCIPAL_INVESTIGATOR)
UC Health	Cincinnati	Ohio	45267	Sonu Jain, MD, FACS [email protected] 513-558-2765 Brittany Rowley, CCRC Clinical Research Professional III [email protected] 513-558-2765 Sonu Jain, MD (PRINCIPAL_INVESTIGATOR)
University of Cincinnati Health	Cincinnati	Ohio	45267	Sonu Jain, MD [email protected] 504-296-8215 Brittany Rowley, Lead Coordinator [email protected] 513-558-2765 Sonu Jain, MD (PRINCIPAL_INVESTIGATOR)
The MetroHealth System	Cleveland	Ohio	44109	Kyle J Chepla, MD [email protected] 216-778-7878 Hannah Amiott, Clinical Research Coordinator [email protected] 216-778-1163 Kyle Chepla, MD (PRINCIPAL_INVESTIGATOR)
The Ohio State University Wexner Medical Center	Columbus	Ohio	43212	Ryan Schmucker, MD [email protected] 614-293-8566 Emily Rice [email protected] 614-293-5871 Ryan Schmucker, MD (PRINCIPAL_INVESTIGATOR)
University of Pennsylvania, Department of Orthopaedic Surgery	Philadelphia	Pennsylvania	19104	Ines C Lin, MD [email protected] 215-662-7300 Annamarie D. Horan, MPA, PhD [email protected] 215-847-0132 Ines C Lin, MD (PRINCIPAL_INVESTIGATOR)
Allegheny Health Network	Pittsburgh	Pennsylvania	15212	Steven Regal, MD [email protected] 877-660-6777 Mary Fetter - Lead Clinical Research Coordinator [email protected] 412-359-8292 Steven Regal, MD (PRINCIPAL_INVESTIGATOR)
Medical University of South Carolina	Charleston	South Carolina	29429	Charles A Daly, MD [email protected] 843-876-2211 Lisa Mock [email protected] 843-876-2211 Charles Daly, MD (PRINCIPAL_INVESTIGATOR)
Baylor, Scott and White Health	Dallas	Texas	75246	Asadullah Helal, MD [email protected] 469-800-7200 Angela Young Young - Clinical Research Coordinator [email protected] 214-820-4787 Asadullah Helal, MD (PRINCIPAL_INVESTIGATOR)
Texas Tech	Lubbock	Texas	79415	Brendan J MacKay, MD [email protected] 806-743-2584 Evan J Hernandez, Clinical Researcher - MBA [email protected] 806-743-6846 Brendan MacKay, MD (PRINCIPAL_INVESTIGATOR)
University of Utah Health	Salt Lake City	Utah	84132	Mark A Mahan, MD, FAANS [email protected] 801-585-7917 Kirstianna Lombardi, Lead Coordinator [email protected] 801-585-9821 Mark Mahan, MD, FAANS (PRINCIPAL_INVESTIGATOR)
UVA Health	Charlottesville	Virginia	22903	Brett DeGeorge, MD [email protected] 434-924-5078 Milos Lesevic, MD [email protected] 434-924-2549 Brett DeGeorge, MD (PRINCIPAL_INVESTIGATOR)
Harborview Medical Center	Seattle	Washington	98104	Yusha ( Katie) Liu, MD PhD [email protected] 206-744-3000 Laura Hennessy, RN [email protected] 206-744-7723 Katie Liu, MD (PRINCIPAL_INVESTIGATOR)

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By research site

Cedars Sinai Medical Center· Los Angeles, CA Orlando Health Orlando Regional Medical Center· Orlando, FL Rothman Orthopedics - Advent Health· Orlando, FL Grady Health· Atlanta, GA University of Chicago· Chicago, IL University of Louisville· Louisville, KY

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