Adenoma Colon
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICEStandard Colonoscopy
In this arm, subjects will undergo colonoscopy using a standard colonoscope
DEVICEDiscovery aided colonoscopy
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.
DEVICEDiscovery and G-EYE
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
Sponsors
Dr. Horst Schmidt Klinik GmbH
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SCREENING
Masking
NONE
Intervention model description
Multi-center, three-arm, randomized, controlled, open-label study
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
Inclusion criteria
1. Screening and surveillance population for Adenoma and CRC. 2. The patient must understand and sign a written informed consent for the procedure.
Exclusion criteria
1. Subjects with inflammatory bowel disease; 2. Subjects with a personal history of hereditary polyposis syndrome; 3. Subjects with suspected chronic stricture potentially precluding complete colonoscopy; 4. Subjects with diverticulitis or toxic megacolon; 5. Subjects with prior colonic surgery (exclusion appendectomy) 6. Subjects with a history of radiation therapy to abdomen or pelvis; 7. Pregnant or lactating female subjects; 8. Subjects who are currently enrolled in another clinical investigation. 9. Subjects with current oral or parenteral use of anticoagulants, not considered eligible by the investigator. 10. Subjects with recent (within the last 3 mounts) coronary ischemia or CVA (stroke) 11. Any patient condition deemed too risky for the study by the investigator
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adenoma detection yield | Upon histology results (up to 30 days) | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adenoma Detection Rate (Discovery + G-EYE vs. Standard Colonoscopy) | Upon histology results (up to 30 days) | Adenoma Detection Rate of Discovery and G-EYE® aided colonoscopy compared to Adenoma Detection Rate of Standard Colonoscopy |
| Adenoma Detection Rate (Discovery vs. Standard Colonosocopy) | Upon histology results (up to 30 days) | Adenoma Detection Rate of Discovery aided colonoscopy compared to Adenoma Detection Rate of Standard Colonoscopy |
| Adenoma Per Colonoscopy (Discovery vs. Discovery + G-EYE) | Upon histology results (up to 30 days) | Adenoma Per Colonoscopy of Discovery aided colonoscopy compared to Adenoma Per Colonoscopy of Discovery and G-EYE® aided colonoscopy |
Countries
Germany
Contacts
Primary ContactRalf Kiesslich, Prof.
Outcome results
None listed