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A Prospective Randomized Comparison of colonoscopy Adenoma Detection Yield of (i) Standard Colonoscopy (SC), (ii) artificial intelligence (Discovery) aided colonoscopy, and (iii) artificial intelligence (Discovery) and permanently mounted balloon (G-EYE®) aided colonoscopy.
Multi-center, three-arm, randomized, controlled, open-label study.
Total of up to 1320 patients will be randomized, including up to 10% for subject drop-out, 440 to each of the three following arms (groups):
Group 1 (1st arm): patients will receive standard colonoscopy (SC) Group 2 (2nd arm): patients will receive colonoscopy aided by the Discovery artificial intelligence software (DC) Group 3 (3rd arm): patients will receive colonoscopy aided by the Discovery artificial intelligence software and the G-EYE® balloon (GDC) The purpose of this study is to compare between the diagnostic yield of Standard Colonoscopy, Discovery aided colonoscopy, and Discovery & G-EYE® aided colonoscopy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Colonoscopy | Active Comparator | Subjects will undergo colonoscopy using a standard colonoscope |
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| Discovery aided colonoscopy | Active Comparator | Subjects will undergo colonoscopy using a a standard colonoscope and the Discovery aided colonoscopy |
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| Discovery and G-EYE aided colonoscopy | Experimental | Subjects will undergo colonoscopy using the G-EYE Endoscope and the Discovery aided colonoscopy |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard Colonoscopy | Device | In this arm, subjects will undergo colonoscopy using a standard colonoscope |
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| Measure | Description | Time Frame |
|---|---|---|
| Adenoma detection yield | adenoma detection yield, represented by Adenoma Per Colonoscopy (APC), of Standard Colonoscopy, compared with APC of Discovery aided colonoscopy and further compared with APC of Discovery & G-EYE® aided colonoscopy | Upon histology results (up to 30 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Adenoma Detection Rate (Discovery + G-EYE vs. Standard Colonoscopy) | Adenoma Detection Rate of Discovery and G-EYE® aided colonoscopy compared to Adenoma Detection Rate of Standard Colonoscopy | Upon histology results (up to 30 days) |
| Adenoma Detection Rate (Discovery vs. Standard Colonosocopy) |
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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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Multi-center, three-arm, randomized, controlled, open-label study
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| Discovery aided colonoscopy | Device | the Discovery is a customized detection support software, developed utilizing AI deep learning technology to support endoscopic lesion detection in the colon. In this arm, a standard colonoscope is used with the Discovery. |
|
| Discovery and G-EYE | Device | The G-EYE® Endoscope is a standard colonoscope which is remanufactured by installing the G-EYE® balloon on the distal bending section of the colonoscope. in this arm, the G-EYE® Endoscope is used with the Discovery |
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Adenoma Detection Rate of Discovery aided colonoscopy compared to Adenoma Detection Rate of Standard Colonoscopy |
| Upon histology results (up to 30 days) |
| Adenoma Per Colonoscopy (Discovery vs. Discovery + G-EYE) | Adenoma Per Colonoscopy of Discovery aided colonoscopy compared to Adenoma Per Colonoscopy of Discovery and G-EYE® aided colonoscopy | Upon histology results (up to 30 days) |