NCT05988645Recruiting
Performance and Safety of MiWEndo-assisted Colonoscopy (MiWEndo II)
Performance and Safety of MiWEndo-assisted Colonoscopy: MiWEndo II (Pivotal Study)
Source: ClinicalTrials.gov · Last updated 8 Oct 2026
Brief summary (registry, in English)
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)
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- First submitted
- 1 Aug 2023
- Start date
- 1 Aug 2023
- Primary completion date
- 29 Nov 2026
- Lead sponsor
- MiWEndo Solutions S.L.
- Diseases
- Colorectal cancer
- NCT number
- NCT05988645
What you commit to
- Study type: Interventional
- Planned participants: 50
- From 1 Aug 2023 to the primary completion date, 29 Nov 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
Other
- ASA-IV patients.
- Urgent colonoscopy.
Who the study is looking for
- \- Patients older than 18-year-old referred for a screening or surveillance colonoscopy because of a high-risk condition of developing colorectal cancer or having colorectal polyps as fecal occult blood test (FOBT) positive, previously resected polyps under surveillance, hereditary polyposis syndromes, Lynch Syndrome or familial cancer.
- These criteria will ensure the probability of finding polyps during the explorations.
- All the patients will give written informed consent.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital Clinic Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.