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

Официальное название

Phase 3, Multicenter, Randomized, Subject and Evaluator Blinded, Controlled Study Evaluating the Safety and Efficacy of NTX-001 Compared to Standard of Care (Neurorrhaphy) in the Treatment of Upper Extremity Transected Nerves Requiring Surgical Repair.

Обзор

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.

Подробное описание

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.

Вмешательства

• Комбинированный продукт 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.

Первичные конечные точки

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

Вторичные конечные точки (12)

• Intraoperative CheckPoint® Stimulation. [Срок оценки: In Operating Room]
• MHQ Total Score [Срок оценки: Screening Visit; Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24, 30, 36, 42, and 48]
• Time to Return to Function [Срок оценки: Screening Visit, Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24, 30, 36, 42, and 48.]
• Change in NPRS [Срок оценки: Screening Visit, Weeks 2, 4, 6, 8, 10, 12,16, 20, 24, 30, 36, 42, and 48]
• Semmes Weinstein Monofilament Test (SWMT) [Срок оценки: Weeks 2, 4, 8, 12, 24, 36, 48.]
• MHQ Two Domain Score [Срок оценки: Screening Visit; Weeks 2, 4, 6, 8, 10, 12, 16, 20, 30, 36, 42, 48]
• Change from Week 2 in MHQ Two Domain Score [Срок оценки: Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24, 30, 36, 42, and 48.]
• Medical Research Council Classification (MRCC) Sensory Score [Срок оценки: Weeks 2, 4, 8, 12, 24, 36, and 48.]
• Medical Research Council Classification (MRCC) Motor Score [Срок оценки: Weeks 2, 4, 8, 12, 24, 36, 48]
• Change from Baseline (W2) in Numeric Pain Rating Scale (NPRS) [Срок оценки: Weeks 2, 24.]
• Patient Global Impression of Change Score [Срок оценки: Weeks 2, 4, 6, 8, 10, 12, 16, 20, 30, 36, 42, and 48]
• Change in Total MHQ Score [Срок оценки: Screening Visit; Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24, 30, 36, 42, and 48.]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

США · 24 центра

• Cedars Sinai Medical Center — Los Angeles
• Rothman Orthopedics - Advent Health — Orlando
• Orlando Health Orlando Regional Medical Center — Orlando
• Grady Health — Atlanta
• University of Chicago — Chicago
• University of Louisville — Louisville
• Louisiana State University Health Sciences Center — New Orleans
• Curtis National Center at MedStar Union Memorial Hospital — Baltimore
• … и ещё 16 центров

Идентификаторы

NCT: NCT06616025 · NTx24301

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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