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Performance and Safety of MiWEndo-assisted Colonoscopy (MiWEndo II)
Sponsor: MiWEndo Solutions S.L.
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 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)
Official title: Performance and Safety of MiWEndo-assisted Colonoscopy: MiWEndo II (Pivotal Study)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
50
Start Date
2023-08-01
Completion Date
2025-12-29
Last Updated
2025-09-29
Healthy Volunteers
No
Conditions
Interventions
MiWEndo System
All colonoscopies will be performed with high-definition technology. The MiWEndo System will be fitted to the tip of the endoscope before colonoscopy is started and connected to the microwave processor unit. Endoscopies will be performed by experienced endoscopists who will be previously trained on the use of the MiWEndo System. The MiWEndo Analyzer will be managed by the assistant. At the beginning of the extubation, the MiWEndo System will be turned on and the endoscopist will put music headphones on (blind to the results of MiWEndo). In case one of them identifies a polyp, the exploration will be stopped and check if it has been detected by the alternative method as well. All the polyps will be resected and sent to the Pathological Department for histological analysis following the usual clinical practice. A stopwatch will be used to measure both total procedure time and withdrawal time.
Locations (1)
Hospital Clinic
Barcelona, Spain