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

Colorectal Cancer Clinical Trial

— EuroCADe  

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05943288
• Other study ID #: CIP2021-AI (OEKG)-01
• Status: Recruiting
• Start date: April 25, 2023
• Est. completion date: March 31, 2025

Study information

• Verified date: August 2023
• Source: Olympus Europe SE & Co. KG
• Contact: Karolin Boecker
• Phone: +49 171 5531717
• Email: karolin.boecker[@]olympus.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 820
• Est. completion date: March 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Device:
• OIP-1
Olympus Endoscopy Computer-Aided Detection (CADe) system

Locations

Country	Name	City	State
Belgium	ZU Leuven	Leuven
Germany	Evangelisches Krankenhaus Düsseldorf	Düsseldorf
Germany	Universitätsklinikum Ulm	Ulm
Spain	Fundación Biomédica Galicia Sur	Pontevedra
Spain	Hospital Universitari I Politécnic La Fe	Valencia
Sweden	Linköping Universitetssjukhus	Linköping

Sponsors (2)

Lead Sponsor	Collaborator
Olympus Europe SE & Co. KG	Cromsource

Countries where clinical trial is conducted

Belgium,  Germany,  Spain,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Adverse events (AEs)	Device-, or procedure-related AEs and Serious AEs (SAEs) reported as incidence (%) and frequency (n).	During procedure
Other	Non-neoplastic resection rate	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	During procedure
Primary	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).	During procedure
Primary	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.	During procedure
Secondary	Adenoma Per Colonoscopy (APC)	Number of histologically proven adenomas (including advanced adenomas) or carcinomas divided by the total number of colonoscopies	During procedure
Secondary	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).	During procedure
Secondary	Endoscope withdrawal time	Time from deepest point of insertion (cecum) needed for complete inspection of the colon, excluding time spent on therapeutic intervention.	During procedure