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

RecruitingPhase 3Ages 18 Years - 80 YearsAllNeuraptive Therapeutics Inc.
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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.
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What it tests

  • NTX-001 (PEG-Fusion)
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Where

25 sites
Cedars Sinai Medical Center
Los Angeles, United States
UCSF Health
San Francisco, United States
Rothman Orthopedics - Advent Health
Orlando, United States
Orlando Health Orlando Regional Medical Center
Orlando, United States
Grady Health
Atlanta, United States
University of Chicago
Chicago, United States
University of Louisville
Louisville, United States
Louisiana State University Health Sciences Center
New Orleans, United States

โ€ฆand 17 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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