Using a microwave device to improve colonoscopy for detecting polyps
Performance and Safety of MiWEndo-assisted Colonoscopy: MiWEndo II (Pivotal Study)
NA · MiWEndo Solutions S.L. · NCT05988645
This study is testing a new microwave device during colonoscopies to see if it can help doctors find more polyps that might be missed with regular methods.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | MiWEndo Solutions S.L. (industry) |
| Locations | 1 site (Barcelona) |
| Trial ID | NCT05988645 on ClinicalTrials.gov |
What this trial studies
This study evaluates the performance and safety of a new microwave-based device, MiWEndo, during colonoscopy procedures in 50 patients. The device aims to enhance the detection of colorectal polyps without altering standard clinical practices. The study is structured as a single-center, prospective, non-comparative investigation, where initial data will be collected to optimize the device's software before further assessments. The primary focus is on identifying polyps that may be missed by traditional endoscopic imaging.
Who should consider this trial
Good fit: Ideal candidates are patients with a previously detected polyp in the rectum who are referred for resection.
Not a fit: Patients at high risk for complications or those requiring urgent colonoscopy may not benefit from this study.
Why it matters
Potential benefit: If successful, this device could lead to earlier detection of colorectal polyps, potentially improving patient outcomes in colorectal cancer screening.
How similar studies have performed: While this approach has been tested in preclinical studies, its application in this specific context is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Barcelona
- Hospital Clinic — Barcelona, Spain (RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Colorectal Cancer, Colorectal Polyp, Colorectal Adenoma, Colorectal Adenomatous Polyp, Colorectal Adenocarcinoma, Colorectal Neoplasms, microwave imaging, colonoscopy