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

Colorectal Cancer Clinical Trial

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

Status Recruiting

Clinical Trial Summary

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)

Clinical Trial Description

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 feasibility of performing a complete colonoscopy using the MiWEndo device.

• To assess the perception of difficulty by the endoscopist when the device is used.

• To assess the operator learning curve with MiWEndo-assisted colonoscopy to guide future recommendations for training.

• 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. ;

Related Conditions & MeSH terms

• Adenoma
• Adenomatous Polyps
• Colorectal Adenocarcinoma
• Colorectal Adenoma
• Colorectal Adenomatous Polyp
• Colorectal Cancer
• Colorectal Neoplasms
• Colorectal Polyp
• Polyps

• NCT number: NCT05988645
• Study type: Interventional
• Source: MiWEndo Solutions S.L.
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2023
• Completion date: December 29, 2024