CompletedNot Applicable

Feasibility and Safety of MiWEndo-assisted Colonoscopy

Spain15 participantsStarted 2022-10-18

Plain-language 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).

Who can participate

Age range50 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: * 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

What they're measuring

Number of incidents and adverse events

Timeframe: During the procedure and up to 2 weeks after

Number of mural injuries

Timeframe: During the procedure

Rate of cecal intubation

Timeframe: During the procedure

Length of colon explored

Timeframe: During the procedure

Trial details

NCT IDNCT05477836

SponsorMiWEndo Solutions S.L.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-11-25

View on ClinicalTrials.gov More Colorectal Cancer trials