MiWEndo1: Feasibility and Safety of MiWEndo-assisted Colonoscopy

Sponsor

MiWEndo Solutions S.L. (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05477836

Collaborator

Hospital Clinic of Barcelona (Other)

Enrollment

Arm

Anticipated Duration (Months)

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Colorectal Cancer Colorectal Polyp Colorectal Adenoma Colorectal Neoplasms Colorectal Adenomatous Polyp Colorectal Adenocarcinoma	Device: MiWEndo-assisted colonoscopy	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

15 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Traditional feasibility study, following a single-center prospective, non-comparative, with few patients design.Traditional feasibility study, following a single-center prospective, non-comparative, with few patients design.

Masking:

None (Open Label)

Primary Purpose:

Device Feasibility

Official Title:

Feasibility and Safety of MiWEndo-assisted Colonoscopy:Pilot Study

Anticipated Study Start Date :

Oct 1, 2022

Anticipated Primary Completion Date :

Nov 1, 2022

Anticipated Study Completion Date :

Jan 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Experimental group	Device: MiWEndo-assisted colonoscopy 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.

Arm

Intervention/Treatment

Experimental: Experimental group

Device: MiWEndo-assisted colonoscopy

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.

Outcome Measures

Primary Outcome Measures

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).
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).
Length of colon explored [During the procedure]
In case cecum could not be reached, the distance will be measured (in cm).

Secondary Outcome Measures

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.
Time for reaching the cecum (or maximum explored colon length) [During the procedure]
Measured in minutes
Total time for completing the procedure [Immediately after 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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