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

Olympus Europe SE & Co. KG850 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

850

Conditions

Colorectal Cancer

Interventions

OIP-1DEVICE

Olympus Endoscopy Computer-Aided Detection (CADe) system

Eligibility

Sex: ALLMin age: 45 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (6)

ZU Leuven

Leuven, Belgium

Evangelisches Krankenhaus Düsseldorf

Düsseldorf, Germany

Universitätsklinikum Ulm

Ulm, Germany

Fundación Biomédica Galicia Sur

Pontevedra, Spain

Outcomes

Primary Outcomes

Adenoma Detection Rate (ADR)

Proportion of patients with at least one histologically confirmed adenoma (including advanced adenomas) or carcinoma in the CADe assisted colonoscopy (CADe+ arm) versus conventional colonoscopy without CAD (CADe- arm).

Time frame: During procedure

Positive Predictive Value (PPV)

Number of histologically confirmed polyps (i.e. adenomas, SSLs, or large (\>10mm) hyperplastic polyps divided by the total number of resections.

Time frame: During procedure

Secondary Outcomes

Adenoma Per Colonoscopy (APC)

Number of histologically proven adenomas (including advanced adenomas) or carcinomas divided by the total number of colonoscopies

Time frame: During procedure

Total Procedure Time

Time from procedure start (insertion of the colonoscope) until colon inspection during a typical withdrawal from cecum to rectosigmoid including any time needed for interventional procedures (biopsies, resection).

Time frame: During procedure

Endoscope withdrawal time

Time from deepest point of insertion (cecum) needed for complete inspection of the colon, excluding time spent on therapeutic intervention.

Time frame: During procedure

Data from ClinicalTrials.gov

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