NCT05477836

Feasibility and Safety of MiWEndo-assisted Colonoscopy

Feasibility and Safety of MiWEndo-assisted Colonoscopy:Pilot Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: MiWEndo Solutions S.L. · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

The study involves the planned use of a new microwave-based device during colonoscopy procedures in a small group of patients to assess the preliminary safety of its use 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 animal model (pig).

Detailed description

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.

Conditions

• Colorectal Cancer
• Colorectal Polyp
• Colorectal Adenoma
• Colorectal Neoplasms
• Colorectal Adenomatous Polyp
• Colorectal Adenocarcinoma

Interventions

Type	Name	Description
DEVICE	MiWEndo-assisted colonoscopy	All colonoscopies will be performed with high-definition technology. The MiWEndo System (MiWEndo Solutions, Barcelona) 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. At the beginning of the extubation, the MiWEndo System will be turned on. During extubation, each segment will be carefully examined with both white light and 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.

Timeline

• Start date: 2022-10-18
• Primary completion: 2022-11-25
• Completion: 2022-11-25
• First posted: 2022-07-28
• Last updated: 2022-11-30

Locations

1 site across 1 country: Spain