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| Name | Class |
|---|---|
| Fujifilm | INDUSTRY |
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The purpose of this study is to compare the additional diagnostic yield over Standard Colonoscopy (i.e., the adenoma miss-rate reduction) obtained by performing CADEYE and G-EYE® aided colonoscopy, vs. the additional diagnostic yield over Standard Colonoscopy (i.e., the adenoma miss-rate reduction) obtained by performing CAD-EYE aided colonoscopy.
The purpose of this study is to compare the additional diagnostic yield over Standard Colonoscopy (i.e., the adenoma miss-rate reduction) obtained by performing CADEYE and G-EYE® aided colonoscopy, vs. the additional diagnostic yield over Standard Colonoscopy (i.e., the adenoma miss-rate reduction) obtained by performing CAD-EYE aided colonoscopy. This is a single-center, four-arm dual-tandem, randomized, open-label study intended to compare the additional detection yield beyond standard colonoscopy obtained by performing combined CAD-EYE and G-EYE® high definition colonoscopy vs. the additional detection yield beyond standard colonoscopy obtained by performing CAD-EYE high definition colonoscopy. Consecutive adult subjects who were referred for elective colonoscopy will be asked to enroll into this randomized clinical study if the candidate meets the study inclusion and exclusion criteria
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Colonoscopy followed by CAD-EYE | Active Comparator | Subjects will undergo standard colonoscopy immediately followed by CAD-EYE colonoscopy (both procedures performed by the same endoscopist in the same sedation session). |
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| CAD-EYE followed by Standard Colonoscopy | Active Comparator | Subjects will undergo CAD-EYE colonoscopy immediately followed by standard colonoscopy (both procedures performed by the same endoscopist in the same sedation session). |
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| Standard Colonoscopy followed by combined CAD-EYE and G-EYE colonoscopy | Active Comparator | Subjects will undergo standard colonoscopy immediately followed by combined CAD-EYE and G-EYE colonoscopy (both procedures performed by the same endoscopist in the same sedation session). |
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| Combined CAD-EYE and G-EYE colonoscopy followed by Standard Colonoscopy | Active Comparator | Subjects will undergo combined CAD-EYE and G-EYE colonoscopy immediately followed by standard colonoscopy (both procedures performed by the same endoscopist in the same sedation session). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard Colonoscopy | Device | Standard Colonoscopy using a standard Fujifilm colonoscope |
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| Measure | Description | Time Frame |
|---|---|---|
| Additional Adenoma Detection | Additional adenoma detection yield (represented by the miss rate) of CAD-EYE and G-EYE® colonoscopy over standard colonoscopy compared to the additional adenoma detection yield of CAD-EYE aided colonoscopy over standard colonoscopy | Upon histology results (up to 30 days) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ralf Kiesslich, Prof. | Contact | +49 611 43-9002 | Ralf.Kiesslich@helios-gesundheit.de |
| Name | Affiliation | Role |
|---|---|---|
| Ralf Kiesslich, Prof. | Helios Dr. Horst Schmidt Kliniken Wiesbaden GmbH | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Helios Dr. Horst Schmidt Kliniken Wiesbaden GmbH | Recruiting | Wiesbaden | 65199 | Germany |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D000236 | Adenoma |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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Subjects will be randomized to one of four groups (arms), Group A1, A2, B1 and B2:
Group A1: Subjects will undergo standard colonoscopy immediately followed by CAD-EYE colonoscopy (both procedures performed by the same endoscopist in the same sedation session). Group A2: Subjects will undergo CAD-EYE colonoscopy immediately followed by standard colonoscopy (both procedures performed by the same endoscopist in the same sedation session). Group B1: Subjects will undergo standard colonoscopy immediately followed by combined CAD-EYE and G-EYE colonoscopy (both procedures performed by the same endoscopist in the same sedation session). Group B2: Subjects will undergo combined CAD-EYE and G-EYE colonoscopy immediately followed by standard colonoscopy (both procedures performed by the same endoscopist in the same sedation session).
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| G-EYE Colonoscopy | Device | G-EYE Colonoscopy performed using SMART Medical G-EYE Colonoscope |
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| CAD-EYE | Device | Colonoscopy performed using with the aid of Fujifilm CAD-EYE artificial intelligence |
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| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |