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Идёт набор NCT07028554

Post-Market Clinical Follow-Up Study Plan for Cartridges of Disposable Endoscopic Linear Cutting Staplers

— Наблюдательное the Transection of Tissues the Resection of Tissues the Creation of Anastomoses

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: Cartridges of Disposable Endoscopic Linear Cutting Staplers, Disposable Powered.
Кому может быть актуально
Состояния в реестре: the Transection of Tissues, the Resection of Tissues, the Creation of Anastomoses. Базовые параметры: от 18 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
Чили
Следующий шаг
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Обзор

Cartridges of Disposable Endoscopic Linear Cutting Staplers, Disposable Powered Endoscopic Linear Cutting Staplers and Disposable Endoscopic Linear Cutting Staplers manufactured by Ningbo Verykind Medical Device Co., Ltd. have marketed in many countries or area for many years. The investigational devices are intended for transection, resection, and/or creation of anastomoses. The instruments have application in multiple open or minimally invasive general, gynecologic, urologic and thoracic surgical procedures. In order to confirm the safety and performance of the products, as well as the continued safety and clinical performance of the implant (the staple) during the clinical follow-up period, monitor the identified side-effects, contraindications and identify previously unknown side-effects, and ensure the continued acceptability of the benefit-risk ratio, Investigators proactively collect and evaluate clinical data from different regions, including of Italy, Brazil and Chile, where the device has been marketed, and conduct PMCF studies.

Вмешательства

  • Устройство Cartridges of Disposable Endoscopic Linear Cutting Staplers, Disposable Powered
    Investigational devices encompassing all models of the Cartridges for Disposable Endoscopic Linear Cutting Staplers, as well as Staplers utilized in conjunction with the Cartridges specified in the Study Plan (Plan number: WEKD-QS-PMCF).

Первичные конечные точки

  • Anastomosis success rate [Срок оценки: The investigation sites will be collected from January 2023 to June 2024.]
Вторичные конечные точки (3)
  • Anastomotic bleeding rate [Срок оценки: The incidence of anastomotic bleeding during day of operation and 6 months after operation was recorded.]
  • Anastomotic leakage rate [Срок оценки: The incidence of leakage during day of operation and 6 months after operation was recorded.]
  • Anastomotic stenosis rate [Срок оценки: The incidence of anastomotic stenosis during day of operation and 6 months after operation was recorded.]

Критерии участия

Критерии включения

  • Age≥18 years old, gender unlimited;
  • The surgery type shall be open or endoscopic surgery;
  • The departments of surgical procedures: general, gynecologic, urologic and thoracic surgical procedures;
  • Investigational devices listed in this PMCF plan must be used during surgical procedures.

Критерии исключения

  • Patients with surgical contraindications to the product, e.g. use the instruments on large arteries, on ischemic or necrotic tissue, use the device on tissues with a compression thickness out of the device range;
  • Concomitant with similar devices (staplers/reloads/cartridges, etc.) for resection, transection and anastomosis of surgical organ or tissues;
  • The operation record is incomplete, and the information related to the main indicators cannot be extracted.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Чили · 1 центр
  • Cartridges of Disposable Endoscopic Linear Cutting Staplers — Ningbo

Идентификаторы

NCT: NCT07028554 · WEKD-QS-PMCF

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗