Finding studies
Finding studies
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Lead
MiWEndo Solutions S.L.
This study is designed as a single-center prospective, non-comparative study in 50 patients, whereby data will be subject to an analytical description, rather than to a statistical treatment (refer to Statistical design and analysis). In this study the principal aims are to assess the performance and safety of the device for the detection of colorectal polyps when used as an accessory to colonoscopy. Relevant claims to verify in this study are that the device will detect in first instance polyps not detected initially with the endoscopic image and can be used without ADEs, without any change in the current clinical practice, as well as without any major difficulty by the endoscopist, neither in the preparation nor in the use of the device during exploration. In addition, in the first phase of the study (n=15 patients), the study aims to gather real clinical data with the use of the device to optimise the processing software that will be key to demonstrate MiWEndo\'s performance on the second part of the study (n=35 patients). Consequently, principal and secondary objectives of this investigation, are: Principal objectives: * To assess the performance of MiWEndo-assisted colonoscopy in the detection of colorectal polyps. * To assess the safety of MiWEndo-assisted colonoscopy. Secondary objectives: * To assess the perception of difficulty by the endoscopist when the device is used. * To provide exploratory analysis of differences in MiWEndo-assisted colonoscopy in different groups of patients to guide future RCT. * To assess the patient's comfort.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
