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Идёт набор NCT04779918

Ventral or Inguinal Hernia, Robotically Repaired With OviTex Mesh

Без фазы С лечением Hernia, Ventral Hernia, Inguinal

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: OviTex Reinforced Tissue Matrix.
Кому может быть актуально
Состояния в реестре: Hernia, Ventral, Hernia, Inguinal. Базовые параметры: от 21 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
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Официальное название

A Prospective Study Evaluating the Clinical Outcomes of Ventral or Inguinal Hernias Treated Robotically With OviTex® Reinforced Tissue Matrix

Обзор

This study is designed to evaluate the post-operative complications and hernia recurrence following the use of OviTex in subjects with ventral or inguinal hernias. Up to 160 subjects will participate in the study from up to 20 investigator sites.

Подробное описание

This study is intended to evaluate the post-operative complications and recurrence following the use of OviTex in ventral or inguinal hernias being treated robotically. It is a single-arm study and all subjects will receive OviTex.

Вмешательства

  • Устройство OviTex Reinforced Tissue Matrix
    All study subjects will receive OviTex. All OviTex Reinforced Tissue Matrices are intended for use as a surgical mesh to reinforce or repair soft tissue where weakness exists.

Первичные конечные точки

  • Early surgical site occurrences or wound related events [Срок оценки: occurring within the first 3 months of the ventral or inguinal hernia repair]
  • Early post-operative complications [Срок оценки: occurring within the first 3 months of the ventral or inguinal hernia repair.]
Вторичные конечные точки (4)
  • Late surgical site occurrences or wound related events [Срок оценки: occurring > 3 months after index surgery]
  • Late post-operative complications [Срок оценки: occurring > 3 months after index surgery.]
  • Patient Reported Outcomes [Срок оценки: Assessed at day 30, day 90, 12 months, and 24 months post-op]
  • Hernia Recurrence [Срок оценки: at post-operative day 90 and months 12 and 24]

Критерии участия

Критерии включения

  • Subject suffers from a ventral or inguinal hernia that requires surgical repair with the use of an implant to reinforce or replace weakened or missing tissue.
  • The patient is scheduled for an elective robotic approach with the use of OviTex LPR, OviTex Core Permanent, OviTex 1S Permanent, or OviTex IHR.
  • The size of the implant needed for repair is expected to be less than or equal to 15 x 25 cm for OviTex LPR and 25 x 40 cm for OviTex Core Permanent and OviTex 1S Permanent, with no size limitation for OviTex IHR.
  • Subject meets CDC/SSI Wound Classification Class I (Clean), Class II (Clean-Contaminated) or Class III (Contaminated) criteria.
  • Subject is willing and able to sign an informed consent for the study and has signed the IRB approved Informed Consent form for this study.
  • Subject is able to complete Quality of Life (QoL) and pain questionnaires.
  • Subject is at least 21 years old.
  • Subject is willing to comply and able to participate fully in, and for the full duration of, the study including follow-up requirements.

Exclusion Criteria at Baseline:

  • Subject has a BMI of > 40
  • Subject meets CDC/SSI Wound Classification Class IV (Dirty-Infected) criteria
  • Subject is female and is pregnant or plans to become pregnant during the course of the study.
  • Subject has a life expectancy of < 2 years making it unlikely that the subject will successfully achieve two-year follow-up.
  • Subject has recent history of drug or alcohol abuse (in last 3 years).
  • Subject has an allergy to ovine-derived products.
  • Subject has participated in another clinical trial within the past 30 days or is currently involved in another clinical trial.
  • Subject has a strangulated hernia.

Exclusion Criteria Intraoperative:

  • Subject requires implant that cannot be introduced into the surgical site during the procedure via port or an existing incision.
  • Subject unable to receive OviTex LPR, OviTex Core Permanent, OviTex 1S Permanent, or OviTex IHR at time of surgery.

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

США · 10 центров
  • University of South Alabama — Mobile
  • SurgOne — Denver
  • GenesisCare — Destin
  • Surgical Healing Arts Center — Fort Myers
  • St. Luke's Hospital — Overland Park
  • University of Louisville — Louisville
  • Munson Healthcare — Traverse City
  • St. Francis Hospital — Roslyn
  • … и ещё 2 центра

Идентификаторы

NCT: NCT04779918 · TB.2020.01.01

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗