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

Launched by MIWENDO SOLUTIONS S.L. · Aug 9, 2023

Keywords

ClinConnect Summary

The MiWEndo II clinical trial is studying a new microwave-based device designed to help doctors find colorectal polyps during colonoscopy procedures. This trial will involve 50 patients and aims to assess how well the device works and its safety. The device has been tested in earlier studies, including tests on human tissue and in a pilot study with people, to ensure it’s ready for use in this clinical setting.

To participate in the trial, patients should be between the ages of 65 to 74 and have a history of certain conditions, such as previously removed polyps or hereditary syndromes like Lynch Syndrome. All participants will need to give written consent before joining the study. It’s important to note that individuals who may be at a higher risk of complications or who have specific medical conditions that could make a full colonoscopy difficult won’t be eligible. If you join the trial, you can expect to undergo a colonoscopy with the new device, and your safety and comfort will be a priority throughout the process.

Gender

ALL

Eligibility 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.