Clinical trial NCT05943288: Safety and Efficacy of the Olympus CADe System in Real-time Colonoscopy
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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Cancer
Keywords: AI (Artificial Intelligence)
CADe (Endoscopy Computer Aided Detection)
Lead sponsor: Olympus Europe SE & Co. KG
Sponsor class: INDUSTRY
Collaborators: name: Cromsource
First posted: 2023-07-13
Enrollment: 850
Sex: ALL
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects undergoing a colonoscopy

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Adenoma Detection Rate (ADR)
timeFrame: During procedure
measure: Positive Predictive Value (PPV)
timeFrame: During procedure
Secondary outcomes:
measure: Adenoma Per Colonoscopy (APC)
timeFrame: During procedure
measure: Total Procedure Time
timeFrame: During procedure
measure: Endoscope withdrawal time
timeFrame: During procedure
Other outcomes:
measure: Adverse events (AEs)
timeFrame: During procedure
measure: Non-neoplastic resection rate
timeFrame: During procedure
Locations:
city: Leuven
country: Belgium
facility: ZU Leuven
city: Düsseldorf
country: Germany
facility: Evangelisches Krankenhaus Düsseldorf
city: Ulm
country: Germany
facility: Universitätsklinikum Ulm
city: Pontevedra
country: Spain
facility: Fundación Biomédica Galicia Sur
city: Valencia
country: Spain
facility: Hospital Universitari I Politécnic La Fe
city: Linköping
country: Sweden
facility: Linköping Universitetssjukhus
Study officials:
affiliation: Olympus Europa SE & Co. KG
name: Karolin Boecker
role: STUDY_DIRECTOR
References: