Finding studies
Finding studies
Take this into the appointment.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Lead
MiWEndo Solutions S.L.
With
This study is designed as a single-center prospective, non-comparative, first in human pilot safety and feasibility study with few 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 aim is to assess the clinical safety of the device and the feasibility of its use in assisted colonoscopy. Relevant claims to verify in this study are that the device 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, 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 a subsequent clinical investigation (pivotal study). Consequently, principal and secondary objectives of this investigation, are: * Principal objectives: * To assess the feasibility of performing a complete colonoscopy using the MiWEndo System. * To assess the safety of MiWEndo colonoscopy. * Secondary objectives: * To assess the perception of difficulty by the endoscopist when the device is used. * To assess the patient's comfort. * To collect data on polyp detection performance to guide possible further improvements of the software before starting the pivotal study.
Age
50–any
Sex
ALL
Healthy volunteers
Not accepted
