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Completed

NCT Number: NCT05943288

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

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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Key information

Conditions

Colorectal Cancer Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

45 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

ZU Leuven, Leuven, Belgium

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Signed informed consent
  • 45-80 years
  • Undergoing colonoscopy for primary CRC screening or postpolypectomy surveillance

Exclusion criteria

  • Lack of informed written consent
  • History of CRC or inflammatory bowel disease or polyposis syndrome / familial adenomatous polyposis coli (FAP)
  • 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
  • Biopsy/anesthesia/sedation contraindications
  • History of radio- and/or chemotherapy
  • Concurrent participation in another competing clinical study

Treatment and study plan

OIP-1

Device

Olympus Endoscopy Computer-Aided Detection (CADe) system

Primary outcomes

  1. Adenoma Detection Rate (ADR)

    Time frame: During procedure

    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).

  2. Positive Predictive Value (PPV)

    Time frame: During procedure

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

Secondary outcomes

  1. Adenoma Per Colonoscopy (APC)

    Time frame: During procedure

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

  2. Total Procedure Time

    Time frame: During procedure

    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).

  3. Endoscope withdrawal time

    Time frame: During procedure

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

Other outcomes

  1. Adverse events (AEs)

    Time frame: During procedure

    Device-, or procedure-related AEs and Serious AEs (SAEs) reported as incidence (%) and frequency (n).

  2. Non-neoplastic resection rate

    Time frame: During procedure

    Number of patients with no histological confirmation of adenoma, advanced adenoma, SSL, large hyperplastic polyp or carcinoma in any excised lesion divided by the number of colonoscopies where at least one polyp was resected

Sponsors and collaborators

Lead sponsor

Olympus Europe SE & Co. KG

Industry

Collaborators

  • Cromsource

Registry information

Official study title

Safety and Efficacy of the Olympus Endoscopy Computer-Aided Detection (CADe) System in Detection of Colorectal Neoplasia's During Real-time Colonoscopy: A European Prospective, Multicenter, Randomized Controlled Trial (EuroCADe)

Acronym: EuroCADe

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jul 13, 2023
Registry last updated
Mar 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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