Safety and Efficacy of the Olympus CADe System in Real-time Colonoscopy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

850 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-04-25

Study Completion Date

2024-07-31

Brief Summary

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This is a prospective, multicenter, randomized Trial to assess the safety and efficacy of the Olympus Endoscopy Computer-Aided Detection (CADe) system, OIP-1, in the detection of colorectal neoplasia's during real-time colonoscopy. The aim of this system is to improve physician performance in the detection of potential mucosal abnormalities during colonoscopy performed for primary Colorectal Cancer screening or postpolypectomy surveillance.

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Detailed Description

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This Study aims to provide insight into whether the application of Artificial Intelligence (Olympus Endoscopy Computer-Aided Detection (CADe) system) increases the detection rate of adenomatous polyps in screening and / or surveillance colonoscopy procedures.

Conditions

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Colorectal Cancer

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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CADe +

Olympus Endoscopy Computer-Aided Detection (CADe) system

OIP-1

Intervention Type DEVICE

Olympus Endoscopy Computer-Aided Detection (CADe) system

CADe -

Standard of Care Endoscopy (HD Whitelight)

No interventions assigned to this group

Interventions

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OIP-1

Olympus Endoscopy Computer-Aided Detection (CADe) system

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Signed informed consent
2. 45-80 years
3. Undergoing colonoscopy for primary CRC screening or postpolypectomy surveillance

Exclusion Criteria

1. Lack of informed written consent
2. History of CRC or inflammatory bowel disease or polyposis syndrome / familial adenomatous polyposis coli (FAP)
3. Prior failed colonoscopy

* multiple historic prior failed colonoscopy due to poor bowel preparation OR
* a single prior failed colonoscopy due to reasons other than poor bowel preparation
4. Biopsy/anesthesia/sedation contraindications
5. History of radio- and/or chemotherapy
6. Concurrent participation in another competing clinical study

Minimum Eligible Age

45 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No