Feasibility and Safety of MiWEndo-assisted Colonoscopy (MiWEndo1)

Feasibility and Safety of MiWEndo-assisted Colonoscopy:Pilot Study

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).

Study Overview

• Status: Completed
• Conditions: Colorectal Neoplasms; Colorectal Cancer; Colorectal Adenoma; Colorectal Adenocarcinoma; Colorectal Polyp; Colorectal Adenomatous Polyp
• Intervention / Treatment: Device: MiWEndo-assisted colonoscopy

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 Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain
    • Hospital Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: DEVICE_FEASIBILITY
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: Experimental group; Microwave-based colonoscopy

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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: MiWEndo Solutions S.L.
• Collaborators: Hospital Clinic of Barcelona

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 18, 2022
• Primary Completion (ACTUAL): November 25, 2022
• Study Completion (ACTUAL): November 25, 2022

Study Registration Dates

• First Submitted: July 21, 2022
• First Submitted That Met QC Criteria: July 26, 2022
• First Posted (ACTUAL): July 28, 2022

Study Record Updates

• Last Update Posted (ACTUAL): November 30, 2022
• Last Update Submitted That Met QC Criteria: November 29, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: colonoscopy; colorectal cancer screening; early diagnosis; microwave imaging
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Pathological Conditions, Anatomical; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Adenoma; Polyps; Adenomatous Polyps
• Other Study ID Numbers: DO-021_CIP1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No