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Набор скоро начнётся NCT07524465

Mochida ReFeel for Digital Nerve Injuries

Фаза IV С лечением Digital Nerve Injury Nerve Reconstruction

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: ReFeel.
Кому может быть актуально
Состояния в реестре: Digital Nerve Injury, Nerve Reconstruction. Базовые параметры: 18 лет — 69 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Investigator-led Observational Clinical Research Project Evaluating the Impact of the ReFeel for Digital Nerve Injuries.

Обзор

This is an Investigator Led single-center, Prospective and Observational, Clinical Research Project. The specific aim of this study is to test/observe the safety and effectiveness of the ReFeel Device for Digital nerve injury in improving recovery time and outcomes. The primary objective of this study is to monitor clinical and surgical procedural outcomes for the use of ReFeel device.

Подробное описание

ReFeel is indicated for the repair of peripheral nerve discontinuities where gap closure can be achieved by flexion of the extremity, or the management of peripheral nerve injuries in which there has been no substantial loss of nerve tissue.

ReFeel is a device used in applications for patients with peripheral nerve discontinuities where gap closure can be achieved by flexion of the extremity, or the management of peripheral nerve injuries in which there has been no substantial loss of nerve tissue.

Despite this common injury there is continued debate on the best treatment algorithm for digital nerve injuries. Digital nerve repair is usually not an option as the field of injury is too large for direct repair. Both conduits and nerve allograft have been used with varying success. Nerve conduits have traditionally been used for gaps less than 2 cm, with allograft for larger gaps.

ReFeel has received 510(k) clearance for a new alginate-based nerve cuff. We propose to conduct an Investigator-led Observational Clinical Research of ReFeel for patients treated with alginate nerve cuff to assess the clinical function following reconstruction.

Вмешательства

  • Устройство ReFeel
    ReFeel is indicated for the repair of peripheral nerve discontinuities where gap closure can be achieved by flexion of the extremity, or the management of peripheral nerve injuries in which there has been no substantial loss of nerve tissue. ReFeel is a device used in applications for patients with peripheral nerve discontinuities where gap closure can be achieved by flexion of the extremity, or the management of peripheral nerve injuries in which there has been no substantial loss of nerve tis

Первичные конечные точки

  • Change from Baseline in Static two-point discrimination [Срок оценки: Baseline, 2 weeks, 6 weeks, 3 months, 6 months, 12 months]
Вторичные конечные точки (5)
  • Change in Visual Analog Scale (VAS) [Срок оценки: Baseline, 2 weeks, 6 weeks, 12 weeks, 3 months, 6 months, 12 months]
  • Water emersion testing [Срок оценки: 2 weeks, 6 weeks, 12 weeks, 3 months, 6 months, 12 months]
  • Physician Satisfaction Score [Срок оценки: Operative]
  • How many nerves were repaired with the provided graft sheet? [Срок оценки: Operative]
  • Change in Range of Motion (ROM) [Срок оценки: Baseline, 2 weeks, 6 weeks, 12 weeks, 3 months, 6 months, 12 months]

Критерии участия

Критерии включения

  • Age 18-69 years
  • Digital nerve injury in at least one digit requiring repair with a gap of 1-25mm
  • Able to provide tension free end to end nerve coaptation
  • Have uninjured contralateral or adjacent digit that is suitable to serve as a referenced digit for baseline functional assessments.
  • Willing to comply with follow up for visits up to 12 months.

Критерии исключения

  • Estimated distance of recovery greater than 150 mm (from proximal site of to the tip of the digit)
  • Injury distal to distal interphalangeal joint
  • Extensive soft tissue injury that will impair recovery assessment
  • Incomplete nerve transections
  • Injury requiring replantation of the target digit
  • Injuries to the affected nerve proximal to the superficial arch
  • Nerve injuries > 24 weeks after initial injury
  • End to side nerve repair
  • Injuries with vascular damage resulting in inadequate perfusion despite repair
  • Subjects with type 1 diabetes or type 2 diabetes requiring regular insulin therapy
  • Subjects who are undergoing or expected to undergo treatment with chemotherapy, radiation therapy, or other know treatment that affects the growth of neural and/or vascular system
  • History of neuropathy, diabetic neuropathy, or another known neuropathy
  • Excepted use of medication during the study that is known to impact nerve regeneration or cause peripheral neuropathy such as immunosuppressant's and Chemotherapeutic
  • History of chronic ischemic condition of the upper extremity.
  • Workers Compensation

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

США · 1 центр
  • OrthoCarolina Research Institute — Charlotte

Идентификаторы

NCT: NCT07524465 · 9220 (ReFeel - 0001)

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗