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Trial Title:
Safety and Efficacy of the Olympus CADe System in Real-time Colonoscopy
NCT ID:
NCT05943288
Condition:
Colorectal Cancer
Conditions: Official terms:
Colorectal Neoplasms
Conditions: Keywords:
AI (Artificial Intelligence)
CADe (Endoscopy Computer Aided Detection)
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Device
Intervention name:
OIP-1
Description:
Olympus Endoscopy Computer-Aided Detection (CADe) system
Arm group label:
CADe +
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.
Criteria for eligibility:
Study pop:
Subjects undergoing a colonoscopy
Sampling method:
Probability Sample
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
Gender:
All
Minimum age:
45 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
ZU Leuven
Address:
City:
Leuven
Zip:
3000
Country:
Belgium
Status:
Recruiting
Facility:
Name:
Evangelisches Krankenhaus Düsseldorf
Address:
City:
Düsseldorf
Zip:
40217
Country:
Germany
Status:
Recruiting
Facility:
Name:
Universitätsklinikum Ulm
Address:
City:
Ulm
Zip:
89081
Country:
Germany
Status:
Recruiting
Facility:
Name:
Fundación Biomédica Galicia Sur
Address:
City:
Pontevedra
Zip:
36071
Country:
Spain
Status:
Active, not recruiting
Facility:
Name:
Hospital Universitari I Politécnic La Fe
Address:
City:
Valencia
Zip:
46026
Country:
Spain
Status:
Not yet recruiting
Facility:
Name:
Linköping Universitetssjukhus
Address:
City:
Linköping
Zip:
58185
Country:
Sweden
Status:
Recruiting
Start date:
April 25, 2023
Completion date:
March 31, 2025
Lead sponsor:
Agency:
Olympus Europe SE & Co. KG
Agency class:
Industry
Collaborator:
Agency:
Cromsource
Agency class:
Industry
Source:
Olympus Europe SE & Co. KG
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05943288
