Colorectal Cancer
Conditions
Keywords
AI (Artificial Intelligence), CADe (Endoscopy Computer Aided Detection)
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.
Interventions
DEVICEOIP-1
Olympus Endoscopy Computer-Aided Detection (CADe) system
Sponsors
Cromsource
Olympus Europe SE & Co. KG
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
45 Years to 80 Years
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 4. Biopsy/anesthesia/sedation contraindications 5. History of radio- and/or chemotherapy 6. Concurrent participation in another competing clinical study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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). |
| Adenoma Per Colonoscopy (APC) | During procedure | Number of histologically proven adenomas (including advanced adenomas) or carcinomas divided by the total number of colonoscopies |
Other
| Measure | Time frame | Description |
|---|---|---|
| Adverse events (AEs) | During procedure | Device-, or procedure-related AEs and Serious AEs (SAEs) reported as incidence (%) and frequency (n). |
| 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 |
Countries
Belgium, Germany, Spain, Sweden
Outcome results
None listed