Performance and Safety of MiWEndo-assisted Colonoscopy (MiWEndo II)

NCT05988645 | Recruiting

• 1 other identifier: MW II-CIP
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The study involves the planned use of a new microwave-based device during colonoscopy procedures in 50 patients to assess the performance and safety of its use for detection of colorectal polyps 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 porcine model) and in a pilot study in humans (NCT05477836)

Conditions

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

Keywords

microwave imaging; colonoscopy; early diagnosis; colorectal cancer screening

Outcome Measures

Primary Outcomes (3)

• Number of polyps

  With MiWEndo assisted colonoscopy, detect at least one polyp before colonoscopy in 10% of patients.

  During the procedure.

• Number of adverse events.

  Number of adverse events related with the use of the MiWEndo using the lexicon proposed by the American Society of Gastrointestinal Endoscopy (ASGE) (Cotton PB et al. GIE 2010;71:446-54).

  During the procedure and up to 2 weeks after.

• Number of mural injuries.

  Mural injuries related with the use of the MiWEndo.

  During the procedure and up to 2 weeks after.

Secondary Outcomes (4)

• Number and size (adenomas and polyps).

  During procedure.

• True positives (TP), False positives (FP), False negatives (FN).

  During procedure.

• Patients' comfort.

  Immediately after the procedure and 2 weeks after.

• Perception of difficulty.

  Immediately after the procedure.

Study Arms (1)

MiWEndo + colonoscope

EXPERIMENTAL

All patients will be explored with MiWEndo as an accessory to colonoscopy

Device: MiWEndo System

Interventions

MiWEndo System DEVICE

All colonoscopies will be performed with high-definition technology. The MiWEndo System 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. The MiWEndo Analyzer will be managed by the assistant. At the beginning of the extubation, the MiWEndo System will be turned on and the endoscopist will put music headphones on (blind to the results of 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.

MiWEndo + colonoscope

Eligibility Criteria

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

You may qualify if:

• \- Patients with a previously detected polyp in the rectum referred for resection.
• These criteria will ensure the probability of finding polyps during the explorations.
• All the patients will give written informed consent.

You may not qualify if:

• Patients at a high risk of having major complications as perforation or hemorrhage, suspected or proven lower gastrointestinal bleeding, non-correctable coagulopathy or anticoagulant/clopidogrel therapy during procedure, inadequate bowel cleansing.
• ASA-IV patients.
• Urgent colonoscopy.

Sponsors & Collaborators

• MiWEndo Solutions S.L.: lead

Study Sites (1)

Hospital Clinic

Barcelona, Spain

RECRUITING

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: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single Group Assignment Traditional safety and performance study, following a single-center prospective and noncomparative.

Study Record Dates

• First Submitted: August 1, 2023
• First Posted: August 14, 2023
• Study Start: August 1, 2023
• Primary Completion: December 29, 2025
• Study Completion: December 29, 2025
• Last Updated: September 29, 2025

Record last verified: 2025-09

Locations

ES (1)