RecruitingNot ApplicableNCT05988645

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

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

Sponsor

MiWEndo Solutions S.L.

Enrollment

50 participants

Start Date

Aug 1, 2023

Study Type

INTERVENTIONAL

Conditions

Colorectal, Cancer Colorectal Neoplasms Colorectal Adenocarcinoma Colorectal Polyp Colorectal Adenoma Colorectal Adenomatous Polyp

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

Min Age: 18 Years

Inclusion Criteria3

\- 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.

Exclusion Criteria3

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.

Interventions

DEVICEMiWEndo 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.