Status:
RECRUITING
Performance and Safety of MiWEndo-assisted Colonoscopy (MiWEndo II)
Lead Sponsor:
MiWEndo Solutions S.L.
Conditions:
Colorectal Cancer
Colorectal Polyp
Eligibility:
All Genders
18+ years
Phase:
NA
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 l...
Detailed Description
This study is designed as a single-center prospective, non-comparative study in 50 patients, whereby data will be subject to an analytical description, rather than to a statistical treatment (refer to...
Eligibility Criteria
Inclusion
- \- 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
- 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.
Key Trial Info
Start Date :
August 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 29 2025
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT05988645
Start Date
August 1 2023
End Date
December 29 2025
Last Update
September 29 2025
Active Locations (1)
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1
Hospital Clinic
Barcelona, Spain