Feasibility and Safety of MiWEndo-assisted Colonoscopy

Not Applicable

Completed

• Conditions: Colorectal Neoplasms; Colorectal Adenoma; Colorectal Adenocarcinoma; Colorectal Cancer; Colorectal Polyp; Colorectal Adenomatous Polyp
• Interventions: Device: MiWEndo-assisted colonoscopy

• Registration Number: NCT05477836
• Lead Sponsor: MiWEndo Solutions S.L.

Brief Summary

The study involves the planned use of a new microwave-based device during colonoscopy procedures in a small group of patients to assess the preliminary safety of its use 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 animal model (pig).

Detailed Description

This study is designed as a single-center prospective, non-comparative, first in human pilot safety and feasibility study with few 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 aim is to assess the clinical safety of the device and the feasibility of its use in assisted colonoscopy. Relevant claims to verify in this study are that the device 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, 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 a subsequent clinical investigation (pivotal study).

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

* Principal objectives:

* To assess the feasibility of performing a complete colonoscopy using the MiWEndo System.

* To assess the safety of MiWEndo colonoscopy.

* Secondary objectives:

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

* To assess the patient's comfort.

* To collect data on polyp detection performance to guide possible further improvements of the software before starting the pivotal study.

Study Timeline

• Study First Submitted: 2022-07-21
• Study First Submitted QC: 2022-07-26
• Study First Posted: 2022-07-28
• Study Start: 2022-10-18
• Status Verified: 2022-11
• Primary Completion: 2022-11-25
• Study Completion: 2022-11-25
• Last Update Submitted: 2022-11-29
• Last Update Posted: 2022-11-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

• Men and women older than 50 years referred for a diagnostic or surveillance colonoscopy and having signed the Informed Consent Form.

Exclusion Criteria

• Patients at a high risk of having major complications as perforation or hemorrhage or in whom the possibility of performing a complete colonoscopy is reduced, including: patients with known colonic strictures, total colectomy, acute diverticulitis, inflammatory bowel disease, suspected or proven lower gastrointestinal bleeding, non-correctable coagulopathy or anticoagulant/clopidogrel therapy during procedure, inadequate bowel cleansing or previous incomplete colonoscopy.
• ASA-IV patients
• Urgent colonoscopy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Experimental group	MiWEndo-assisted colonoscopy	Microwave-based colonoscopy

Primary Outcome Measures

Name	Time	Method
Number of mural injuries	During the procedure	To assess the safety of MiWEndo colonoscopy according to the Sydney classification for deep mural injuries (DMI)
Rate of cecal intubation	During the procedure	To assess the feasibility of performing a complete colonoscopy using the MiWEndo System. This parameter will be measured as complete colonoscopy (yes/no).
Number of incidents and adverse events	During the procedure and up to 2 weeks after	To assess the safety of MiWEndo colonoscopy using the lexicon proposed by the American Society of Gastrointestinal Endoscopy (ASGE).
Length of colon explored	During the procedure	In case cecum could not be reached, the distance will be measured (in cm).

Secondary Outcome Measures

Name	Time	Method
Total time for completing the procedure	Immediately after the procedure	Measured in minutes
Time for reaching the cecum (or maximum explored colon length)	During the procedure	Measured in minutes
Perception of difficulty	Immediately after the procedure	Difficulty by the endoscopist subjectively assessed based on a 5-points Likert scale, where 0 is not difficult and 4 is very difficult.
Patients' comfort	Immediately after the procedure and 2 weeks after	Subjective assessment from patient following the Gloucester 5-Likert scale, where 1 is no discomfort and 5 is extreme discomfort.

Trial Locations

Locations (1)

Hospital Clínic; 🇪🇸 Barcelona, Spain