Adenoma Colon Clinical Trial
Official title:
Comparison of Colonoscopy Adenoma Detection Yield of Standard Colonoscopy, Discovery Aided Colonoscopy, and Discovery and G-EYE® Aided Colonoscopy
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.
Status | Recruiting |
Enrollment | 1320 |
Est. completion date | June 2022 |
Est. primary completion date | May 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | N/A and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Germany | Helios Dr. Horst Schmidt Kliniken Wiesbaden GmbH | Wiesbaden |
Lead Sponsor | Collaborator |
---|---|
Dr. Horst Schmidt Klinik GmbH |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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) | |
Secondary | 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) | |
Secondary | Adenoma Detection Rate (Discovery vs. Standard Colonosocopy) | Adenoma Detection Rate of Discovery aided colonoscopy compared to Adenoma Detection Rate of Standard Colonoscopy | Upon histology results (up to 30 days) | |
Secondary | 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) |
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