Performance and Safety of MiWEndo-assisted Colonoscopy (MiWEndo II)

Официальное название

Performance and Safety of MiWEndo-assisted Colonoscopy: MiWEndo II (Pivotal Study)

Обзор

The study involves the planned use of a new microwave-based device during colonoscopy procedures in 50 patients to assess the performance and safety of its use for detection of colorectal polyps and lack of normal clinical practice modification. The device is a final design version, which has been previously tested in several preclinical studies (including phantom studies, an ex vivo study with human tissues, and an in vivo study with porcine model) and in a pilot study in humans (NCT05477836)

Подробное описание

This study is designed as a single-center prospective, non-comparative study in 50 patients, whereby data will be subject to an analytical description, rather than to a statistical treatment (refer to Statistical design and analysis).

In this study the principal aims are to assess the performance and safety of the device for the detection of colorectal polyps when used as an accessory to colonoscopy. Relevant claims to verify in this study are that the device will detect in first instance polyps not detected initially with the endoscopic image and can be used without ADEs, without any change in the current clinical practice, as well as without any major difficulty by the endoscopist, neither in the preparation nor in the use of the device during exploration.

In addition, in the first phase of the study (n=15 patients), the study aims to gather real clinical data with the use of the device to optimise the processing software that will be key to demonstrate MiWEndo\'s performance on the second part of the study (n=35 patients).

Consequently, principal and secondary objectives of this investigation, are:

Principal objectives:

* To assess the performance of MiWEndo-assisted colonoscopy in the detection of colorectal polyps. * To assess the safety of MiWEndo-assisted colonoscopy.

Secondary objectives:

* To assess the perception of difficulty by the endoscopist when the device is used. * To provide exploratory analysis of differences in MiWEndo-assisted colonoscopy in different groups of patients to guide future RCT. * To assess the patient's comfort.

Вмешательства

• Устройство MiWEndo System
  All colonoscopies will be performed with high-definition technology. The MiWEndo System will be fitted to the tip of the endoscope before colonoscopy is started and connected to the microwave processor unit. Endoscopies will be performed by experienced endoscopists who will be previously trained on the use of the MiWEndo System. The MiWEndo Analyzer will be managed by the assistant. At the beginning of the extubation, the MiWEndo System will be turned on and the endoscopist will put music headp

Первичные конечные точки

• Number of polyps [Срок оценки: During the procedure.]
• Number of adverse events. [Срок оценки: During the procedure and up to 2 weeks after.]
• Number of mural injuries. [Срок оценки: During the procedure and up to 2 weeks after.]

Вторичные конечные точки (4)

• Number and size (adenomas and polyps). [Срок оценки: During procedure.]
• True positives (TP), False positives (FP), False negatives (FN). [Срок оценки: During procedure.]
• Patients' comfort. [Срок оценки: Immediately after the procedure and 2 weeks after.]
• Perception of difficulty. [Срок оценки: Immediately after the procedure.]

Критерии участия

Критерии включения

\- Patients with a previously detected polyp in the rectum referred for resection.

These criteria will ensure the probability of finding polyps during the explorations.

All the patients will give written informed consent.

Критерии исключения

• Patients at a high risk of having major complications as perforation or hemorrhage, suspected or proven lower gastrointestinal bleeding, non-correctable coagulopathy or anticoagulant/clopidogrel therapy during procedure, inadequate bowel cleansing.
• ASA-IV patients.
• Urgent colonoscopy.

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

Диагностика

Центры проведения

Испания · 1 центр

• Hospital Clinic — Barcelona

Идентификаторы

NCT: NCT05988645 · MW II-CIP

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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