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| Name | Class |
|---|---|
| Cromsource | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CADe + | Olympus Endoscopy Computer-Aided Detection (CADe) system |
| |
| CADe - | Standard of Care Endoscopy (HD Whitelight) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OIP-1 | Device | Olympus Endoscopy Computer-Aided Detection (CADe) system |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Adenoma Per Colonoscopy (APC) | Number of histologically proven adenomas (including advanced adenomas) or carcinomas divided by the total number of colonoscopies | During procedure |
| Total Procedure Time |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events (AEs) | Device-, or procedure-related AEs and Serious AEs (SAEs) reported as incidence (%) and frequency (n). | During procedure |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
Lack of informed written consent
History of CRC or inflammatory bowel disease or polyposis syndrome / familial adenomatous polyposis coli (FAP)
Prior failed colonoscopy
Biopsy/anesthesia/sedation contraindications
History of radio- and/or chemotherapy
Concurrent participation in another competing clinical study
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Subjects undergoing a colonoscopy
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| Name | Affiliation | Role |
|---|---|---|
| Karolin Boecker | Olympus Europa SE & Co. KG | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ZU Leuven | Leuven | 3000 | Belgium | |||
| Evangelisches Krankenhaus Düsseldorf |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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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 |
| 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 |
| During procedure |
| Düsseldorf |
| 40217 |
| Germany |
| Universitätsklinikum Ulm | Ulm | 89081 | Germany |
| Fundación Biomédica Galicia Sur | Pontevedra | 36071 | Spain |
| Hospital Universitari I Politécnic La Fe | Valencia | 46026 | Spain |
| Linköping Universitetssjukhus | Linköping | 58185 | Sweden |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |