Safety and Efficacy of NTX-001 Compared to SOC in Acute Single Peripheral Nerve Injuries
NCT ID: NCT04572906
Last Updated: 2024-11-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
51 participants
INTERVENTIONAL
2020-09-25
2024-06-27
Brief Summary
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Detailed Description
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NTX-001 has been developed as a surgical product to be used in conjunction with standard suture neurorrhaphy of a severed nerve. Use of NTX-001 is intended to safely accelerate the often slow and diminished return of function in repaired nerves. It often takes months and/or years to determine if function will be restored. By that point, restoration is often incomplete and can result in lifelong motor and/or sensory deficits. By reconnecting (PEG-fusion) a substantial number of axons within a severed nerve, the degeneration-regeneration cycle and subsequent atrophy may be reduced or even prevented for those axons and their targets, respectively. NTX-001 (PEG-fusion) has the potential to avoid the consequences of protracted denervation of distal target tissues by eliminating the period of total denervation thus reducing the time to stable recovery and providing greater innervation to affected tissues.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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NTX-001
NTX-001 used during surgical repair of an upper extremity peripheral nerve injury in conjuction with standard suture neurorrhaphy.
NTX-001
One time use surgical product, 3 solutions applied topically, in sequence, to the peripheral nerve repair site, in conjunction with standard suture neurorrhaphy. An isolation chamber medical device (device) is utilized to focus the application of PEG (Solution #2) on the coapted nerve for the required amount of exposure time.
Standard of Care
standard suture neurorrhaphy
No interventions assigned to this group
Interventions
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NTX-001
One time use surgical product, 3 solutions applied topically, in sequence, to the peripheral nerve repair site, in conjunction with standard suture neurorrhaphy. An isolation chamber medical device (device) is utilized to focus the application of PEG (Solution #2) on the coapted nerve for the required amount of exposure time.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* The subject has sustained a confirmed (intra-op assessment) single transected peripheral nerve injury.
* The subject's nerve injury is classified as Sunderland's Fourth and Fifth Degree (Class III)
* The subject's nerve injury is amenable to minimal or acceptable tension, in direct, end-to-end repair.
* The surgical repair will occur within 48 hours of injury.
Exclusion Criteria
* Other treatments known to affect the growth and/or physiology of the neural and vascular system.
* The nerve injury has vascular damage that cannot be repaired to provide adequate perfusion of the injured site.
* The subject is pregnant and/or is breastfeeding.
* The subject has a significant medical comorbidity precluding immediate repair.
12 Years
80 Years
ALL
No
Sponsors
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Neuraptive Therapeutics Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Seth Schulman, MD
Role: STUDY_CHAIR
Neuraptive Therapeutics Inc.
Locations
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UF Health - University of FL - Gainesville
Gainesville, Florida, United States
Orlando Health
Orlando, Florida, United States
University of Chicago
Chicago, Illinois, United States
Indiana Hand to Shoulder Center
Indianapolis, Indiana, United States
Curtis National Hand Center
Baltimore, Maryland, United States
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, United States
Washington University
St Louis, Missouri, United States
The Ohio State University Wexner Medical Center Hand and Upper Extremity Center
Columbus, Ohio, United States
Virginia Commonwealth University
Richmond, Virginia, United States
Harborview Medical Center
Seattle, Washington, United States
Countries
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References
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Ghergherehchi CL, Mikesh M, Sengelaub DR, Jackson DM, Smith T, Nguyen J, Shores JT, Bittner GD. Polyethylene glycol (PEG) and other bioactive solutions with neurorrhaphy for rapid and dramatic repair of peripheral nerve lesions by PEG-fusion. J Neurosci Methods. 2019 Feb 15;314:1-12. doi: 10.1016/j.jneumeth.2018.12.015. Epub 2018 Dec 23.
Mikesh M, Ghergherehchi CL, Louis Hastings R, Ali A, Rahesh S, Jagannath K, Sengelaub DR, Trevino RC, Jackson DM, Bittner GD. Corrigendum to "Polyethylene glycol solutions rapidly restore and maintain axonal continuity, neuromuscular structures, and behaviors lost after sciatic nerve transections in female rats.". J Neurosci Res. 2018 Sep;96(9):1623. doi: 10.1002/jnr.24277. No abstract available.
Mikesh M, Ghergherehchi CL, Rahesh S, Jagannath K, Ali A, Sengelaub DR, Trevino RC, Jackson DM, Tucker HO, Bittner GD. Corrigendum to "Polyethylene glycol treated allografts not tissue matched nor immunosuppressed rapidly repair sciatic nerve gaps, maintain neuromuscular functions, and restore voluntary behaviors in female rats". J Neurosci Res. 2018 Sep;96(9):1624. doi: 10.1002/jnr.24278. No abstract available.
Bittner GD, Spaeth CS, Poon AD, Burgess ZS, McGill CH. Repair of traumatic plasmalemmal damage to neurons and other eukaryotic cells. Neural Regen Res. 2016 Jul;11(7):1033-42. doi: 10.4103/1673-5374.187019.
Bittner GD, Sengelaub DR, Trevino RC, Peduzzi JD, Mikesh M, Ghergherehchi CL, Schallert T, Thayer WP. The curious ability of polyethylene glycol fusion technologies to restore lost behaviors after nerve severance. J Neurosci Res. 2016 Mar;94(3):207-30. doi: 10.1002/jnr.23685. Epub 2015 Nov 3.
Other Identifiers
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NTx20201
Identifier Type: -
Identifier Source: org_study_id
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