Идёт набор NCT06895785

Exalt Single-use Duodenoscope Vs Reusable Scope, a Randomized Controlled Trial

Без фазы С лечением Biliary Diseases Pancreatic Duct Disorder

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: Exalt Model D, Reusable.
Кому может быть актуально: Состояния в реестре: Biliary Diseases, Pancreatic Duct Disorder. Базовые параметры: от 19 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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Обзор

This randomized controlled trial (RCT) is designed to evaluate the new generation Exalt Model disposable duodenoscope compared to the reusable scope in terms of feasibility, ease of use, adverse events, number of crossover events, and infection rates.

Подробное описание

To ensure a safe and high-quality endoscopy, there are multiple disinfection protocols for endoscopes. Side-viewing duodenoscopes with an adjustable accessory device (elevator) contain potential blind spots for debris and bacteria that require specialized cleaning and disinfection methods beyond standard protocols for other endoscopes. It is thought that the duodenoscope's design, persistent postprocedural microbial contamination and biofilm formation make it more prone to cross-contamination5. Gromski et al, found there are documented pathogenic transmissions, which led to harm in multiple patients and centers3. Infection control was likely related to two major components, reusable duodenoscopes and procedural factors related to how the reusable duodenoscopes were reprocessed3. Multidrug-resistant organisms, such as carbapenem-resistant Enterobacteriaceae, that were associated with reusable duodenoscopes lead the FDA to mandate the transition to improved cleaning and disinfection methods or single-use platforms to eliminate infection transmission. One such single-use platform is the Exalt Model D (Boston Scientific, Marlboro, MA), which received FDA approval in 2020 for use of single-use duodenoscopes. Early iterations of the Exalt were used on a case-by-case basis per institution-specific protocols, mainly due to the learning curve involved with using the scope. A new version of Exalt has been released to market in 2023 with modifications that may make it more feasible to use in all settings requiring a duodenoscope. This randomized controlled trial (RCT) is designed to evaluate the new generation Exalt Model disposable duodenoscope compared to the reusable scope in terms of feasibility, ease of use, adverse events, number of crossover events, and infection rates.

Вмешательства

Устройство Exalt Model D
Exalt Model D single-use duodenoscope will be used in ERCP
Устройство Reusable
Standard reusable duodenoscope will be used in ERCP

Первичные конечные точки

Number of attempts required to achieve successful cannulation of the desired duct [Срок оценки: From the time of the ERCP to 7 days post-ERCP per standard of care]

Вторичные конечные точки (5)

Crossover single to reusable [Срок оценки: From the start of the ERCP to the end of procedure]
Use of advanced cannulation techniques [Срок оценки: From the start of the ERCP to the end of procedure]
Performance on ERCP maneuvers [Срок оценки: From the start of the ERCP to the end of procedure]
Adverse events [Срок оценки: From the completion of the ERCP to 7 days post-ERCP per standard of care]
Endoscopist-determined ease of use [Срок оценки: From the start of the ERCP to the end of procedure]

Критерии участия

Критерии включения

All patients > 18 years old who have biliary or pancreatic duct disorder, based on clinical symptoms and radiological findings at CT or magnetic resonance cholangiopancreatography
Native papilla