Performance and Safety of MiWEndo-assisted Colonoscopy: MiWEndo II (Pivotal Study)

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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)

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• \- 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.

Locations
Other Locations
Spain
Hospital Clinic
RECRUITING
Barcelona
Time Frame
Start Date: 2023-08-01
Estimated Completion Date: 2025-12-29
Participants
Target number of participants: 50
Treatments
Experimental: MiWEndo + colonoscope
All patients will be explored with MiWEndo as an accessory to colonoscopy
Related Therapeutic Areas
Sponsors
Leads: MiWEndo Solutions S.L.

This content was sourced from clinicaltrials.gov

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