Feasibility and Safety of MiWEndo-assisted Colonoscopy

NCT05477836 | Completed

• 1 other identifier: DO-021_CIP1
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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).

Conditions

Colorectal Cancer; Colorectal Polyp; Colorectal Adenoma; Colorectal Neoplasms; Colorectal Adenomatous Polyp; Colorectal Adenocarcinoma

Keywords

microwave imaging; colonoscopy; early diagnosis; colorectal cancer screening

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (4)

• Patients' comfort

  Immediately after the procedure and 2 weeks after

• Time for reaching the cecum (or maximum explored colon length)

  During the procedure

• Total time for completing the procedure

  Immediately after the procedure

• Perception of difficulty

  Immediately after the procedure

Study Arms (1)

Experimental group

EXPERIMENTAL

Microwave-based colonoscopy

Device: MiWEndo-assisted colonoscopy

Interventions

MiWEndo-assisted colonoscopy DEVICE

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.

Experimental group

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• MiWEndo Solutions S.L.: lead
• Hospital Clinic of Barcelona: collaborator

Study Sites (1)

Hospital Clínic

Barcelona, Spain

Location

MeSH Terms

Conditions

Colorectal Neoplasms; Disease

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: July 21, 2022
• First Posted: July 28, 2022
• Study Start: October 18, 2022
• Primary Completion: November 25, 2022
• Study Completion: November 25, 2022
• Last Updated: November 30, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)