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 Orlando, Florida.

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

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 (18)

Facility	City	State	ZIP	Site coordinators
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)
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)
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)
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)
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)
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

Orlando Health Orlando Regional Medical Center· Orlando, FL Grady Health· Atlanta, GA University of Chicago· Chicago, IL Louisiana State University Health Sciences Center· New Orleans, LA Curtis National Center at MedStar Union Memorial Hospital· Baltimore, MD Missouri Orthopaedic Institute· Columbia, MO

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