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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMiWEndo Solutions S.L.

About this trial

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)

Eligibility criteria

Qualifiers

None

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • MiWEndo System

Treatment groups

50 Participants
are divided into 1 treatment group

Sponsors and collaborators