Actively Recruiting
Performance and Safety of MiWEndo-assisted Colonoscopy (MiWEndo II)
Led by MiWEndo Solutions S.L. · Updated on 2025-09-29
50
Participants Needed
1
Research Sites
125 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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)
CONDITIONS
Official Title
Performance and Safety of MiWEndo-assisted Colonoscopy (MiWEndo II)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with a previously detected polyp in the rectum referred for resection
- Patients must provide written informed consent
You will not qualify if you...
- Patients at high risk of major complications such as perforation or hemorrhage
- Patients with suspected or proven lower gastrointestinal bleeding
- Patients with non-correctable coagulopathy or on anticoagulant/clopidogrel therapy during procedure
- Patients with inadequate bowel cleansing
- ASA-IV patients
- Patients requiring urgent colonoscopy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Hospital Clinic
Barcelona, Spain
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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