A Clinical Study on Endoscopic and Histopathological Outcomes of Screening and Surveillance Colonoscopies (CODACO)

Olympus

Status: Enrolling

Conditions: Colonic Polyp

Treatments: Device: Colonoscopy

Study type: Observational

Funder types: Industry

Identifiers

NCT05869838

2023-001

Details and patient eligibility

About

The objective of this study is to collect colonoscopy data for use in the development and testing of artificial intelligence (AI) devices for colonoscopies.

Full description

The primary objective of this study is to collect colonoscopy data for use in the development and performance evaluation of AI devices. The data will be collected during routine colonoscopy procedures. Biopsy or resection will be performed if needed and all specimens will be sent for histopathological examination. The histopathological results will be recorded.

Enrollment: 600 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients aged 18 years or older
• Patients who have signed a written consent form from their voluntary decision after receiving thorough explanation on this study and fully understanding the explanation prior to participation in the study
• Patients who plan to receive colonoscopy procedure and meet any of the following conditions: Colon cancer screening, post-polypectomy surveillance, patients who are advised by a physician to take a colonoscopy exam

Exclusion criteria

• Patients for whom endoscopic submucosal dissection is planned
• Patients for whom polypectomy is difficult to perform due to antithrombotic therapy received etc.
• Patients who have to receive an urgent colonoscopy procedure
• Patients who underwent total colectomy of the large intestine
• Patients who are judged by a physician to be contraindicated for colonoscopy procedures
• Patients who have participated in another clinical study within the last 30 days