Feasibility and Safety of MiWEndo-assisted Colonoscopy (MiWEndo1)

MiWEndo Solutions

Status

Completed

Conditions

Colorectal Adenocarcinoma

Colorectal Adenomatous Polyp

Colorectal Adenoma

Colorectal Polyp

Colorectal Neoplasms

Colorectal Cancer

Treatments

Device: MiWEndo-assisted colonoscopy

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT05477836

DO-021_CIP1

Details and patient eligibility

About

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).

Full 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.

Enrollment

15 patients

Sex

All

Ages

50+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Men and women older than 50 years referred for a diagnostic or surveillance colonoscopy and having signed the Informed Consent Form.

Exclusion criteria

Patients at a high risk of having major complications as perforation or hemorrhage or in whom the possibility of performing a complete colonoscopy is reduced, including: patients with known colonic strictures, total colectomy, acute diverticulitis, inflammatory bowel disease, suspected or proven lower gastrointestinal bleeding, non-correctable coagulopathy or anticoagulant/clopidogrel therapy during procedure, inadequate bowel cleansing or previous incomplete colonoscopy.
ASA-IV patients
Urgent colonoscopy