RecruitingNot Applicable

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

Spain50 participantsStarted 2023-08-01

Plain-language 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)

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: \- 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. Exclusion Criteria: * 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.

What they're measuring

Number of polyps

Timeframe: During the procedure.

Number of adverse events.

Timeframe: During the procedure and up to 2 weeks after.

Number of mural injuries.

Timeframe: During the procedure and up to 2 weeks after.

Trial details

NCT IDNCT05988645

SponsorMiWEndo Solutions S.L.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-12-29

View on ClinicalTrials.gov More Colorectal Cancer trials