Feasibility and Safety of MiWEndo-assisted Colonoscopy

Study Overview
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Brief Summary
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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
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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.

Official Title
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Feasibility and Safety of MiWEndo-assisted Colonoscopy:Pilot Study

Conditions
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Colorectal Cancer, Colorectal Polyp, Colorectal Adenoma, Colorectal Neoplasms, Colorectal Adenomatous Polyp, Colorectal Adenocarcinoma

Intervention / Treatment
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* Device: MiWEndo-assisted colonoscopy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Intervention Model: Single Group Assignment
Interventional Model Description: Traditional feasibility study, following a single-center prospective, non-comparative, with few patients design.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental group<br>Microwave-based colonoscopy | Device: MiWEndo-assisted colonoscopy<br>* All colonoscopies will be performed with high-definition technology. The MiWEndo System (MiWEndo Solutions, Barcelona) 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. At the beginning of the extubation, the MiWEndo System will be turned on. During extubation, each segment will be carefully examined with both white light and MiWEndo. In case one of them identifies a polyp, the exploration will be stopped and check if it has been detected by the alternative method as well. All the polyps will be resected and sent to the Pathological Department for histological analysis following the usual clinical practice. A stopwatch will be used to measure both total procedure time and withdrawal time.<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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microwave imaging, colonoscopy, early diagnosis, colorectal cancer screening