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

• Sponsor: Olympus Europe SE & Co. KG (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT05943288
• Collaborator: Cromsource (Industry)
• Enrollment: 820
• Location: 1
• Anticipated Duration (Months): 10.2
• Patients Per Site Per Month: 80.8

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Colorectal Cancer	Device: OIP-1

Detailed Description

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 Design

• Study Type: Observational
• Anticipated Enrollment: 820 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official 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)
• Actual Study Start Date: Apr 25, 2023
• Anticipated Primary Completion Date: Oct 1, 2023
• Anticipated Study Completion Date: Feb 28, 2024

Arms and Interventions

Arm	Intervention/Treatment
CADe + Olympus Endoscopy Computer-Aided Detection (CADe) system	Device: OIP-1; Olympus Endoscopy Computer-Aided Detection (CADe) system
CADe - Standard of Care Endoscopy (HD Whitelight)

Outcome Measures

Primary Outcome Measures

1. Adenoma Detection Rate (ADR) [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) [During procedure]

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

Secondary Outcome Measures

1. Adenoma Per Colonoscopy (APC) [During procedure]

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

2. Total Procedure Time [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 [During procedure]

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

Other Outcome Measures

1. Adverse events (AEs) [During procedure]

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

2. Non-neoplastic resection rate [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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 45 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

1. Biopsy/anesthesia/sedation contraindications

2. History of radio- and/or chemotherapy

3. Concurrent participation in another competing clinical study

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Universitätsklinikum Ulm	Ulm		Germany	89081

Sponsors and Collaborators

• Olympus Europe SE & Co. KG
• Cromsource

Investigators

• Study Director: Karolin Boecker, Olympus Europa SE & Co. KG

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Olympus Europe SE & Co. KG
• ClinicalTrials.gov Identifier: NCT05943288
• Other Study ID Numbers: CIP2021-AI (OEKG)-01
• First Posted: Jul 13, 2023
• Last Update Posted: Jul 13, 2023
• Last Verified: Jul 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Olympus Europe SE & Co. KG: AI (Artificial Intelligence); CADe (Endoscopy Computer Aided Detection)
• Additional relevant MeSH terms: Colorectal Neoplasms

Study Results

No Results Posted as of Jul 13, 2023