Performance Characteristics and Technical Outcomes of Single-use vs. Reusable Gastroscopes Evaluated in the OR

Официальное название

Performance Characteristics and Technical Outcomes of Single-use Versus Reusable Gastroscopes Evaluated in the Operating Room in Acute, Subacute and Elective Patients

Обзор

The goal of this clinical trial is to investigate whether single-use gastroscopes are as good as reusable gastroscopes when used in the operation theater in all patients where gastroscopy in the operation theater is indicated. The main question it aims to answer is: \- Is the technical success and performance characteristics the same for single-use and reusable gastroscopies? Researchers will compare single-use gastroscopes with reusable gastroscopes to see if the technical success and performance characteristics are the same in the to groups. Participants will in the first period have gastroscopy with a single-use gastroscope. In the second period participants will have gastroscopy with a reusable gastroscope.

Вмешательства

• Устройство Ambu aScope Gastro
  CE-marked single-use gastroscopes from Ambu are used in the single-use group.
• Устройство Ambu aScope Gastro Large
  CE-marked single-use gastroscopes from Ambu are used in the single-use group.
• Устройство Diagnostic gastroscopes, Olympus
  Reusable gastroscopes from Olympus are used in the reusable group.
• Устройство Therapeutic gastroscopes, Olympus
  Reusable gastroscopes from Olympus are used in the reusable group.

Первичные конечные точки

• Technical success of single-use gastroscopes vs reusable gastroscopes [Срок оценки: From admission to discharge, up to 3 months]

Вторичные конечные точки (9)

• Complications [Срок оценки: 24 hours and 72 hours follow-up after procedure]
• 30th day mortality [Срок оценки: 30 days]
• Endoscopist's rating of gastroscope [Срок оценки: Right after procedure]
• Duration of procedure [Срок оценки: During the procedure]
• Time from procedure to discharge [Срок оценки: From procedure to discharge, up to 3 months]
• Success of specific therapeutic procedures [Срок оценки: During the procedure]
• Need of new gastroscopy [Срок оценки: During admission, up to 3 months]
• Readmission [Срок оценки: 30 days after procedure]
• Sufficient ability to target the biopsy if taken [Срок оценки: During procedure]

Критерии участия

Критерии включения

• Acute, subacute or elective gastroscopies in the operating theater
• Age ≥ 18 years

Критерии исключения

• None

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Дания · 1 центр

• Zealand University Hospital — Køge

Публикации

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Идентификаторы

NCT: NCT06581016 · SUSUES_COP

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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