Adenoma, Colorectal Cancer
Conditions
Keywords
G-EYE, Colonoscopy, CAD-EYE, Adenoma, Colorectal Cancer
Brief summary
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.
Detailed description
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
Interventions
DEVICEStandard Colonoscopy
Standard Colonoscopy using a standard Fujifilm colonoscope
DEVICEG-EYE Colonoscopy
G-EYE Colonoscopy performed using SMART Medical G-EYE Colonoscope
DEVICECAD-EYE
Colonoscopy performed using with the aid of Fujifilm CAD-EYE artificial intelligence
Sponsors
Fujifilm
Smart Medical Systems Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SCREENING
Masking
NONE
Intervention model description
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).
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Screening and surveillance population for Adenoma and CRC. 2. Subjects age is at least 18 years 3. 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 |
|---|---|---|
| Additional Adenoma Detection | Upon histology results (up to 30 days) | 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 |
Countries
Germany
Contacts
Primary ContactRalf Kiesslich, Prof.
Outcome results
None listed