Status:
UNKNOWN
A Prospective Randomized Study Comparing the Adenoma Detection Yield of SC, AI and Combined AI and G-EYE®
Lead Sponsor:
Smart Medical Systems Ltd.
Conditions:
Colorectal (Colon or Rectal) Cancer
Adenoma
Eligibility:
All Genders
45+ years
Phase:
NA
Brief Summary
This is a multicenter, 3-arm, randomized, open-label study. Subjects referred to colonoscopy for screening or surveillance will be randomized in a 2:5:5 into one of the following arms: (i) Standard C...
Detailed Description
This is a multicenter, 3-arm, randomized, open-label study. Subjects referred to colonoscopy for screening or surveillance will be randomized in a 2:5:5 into one of the following arms: (i) Standard C...
Eligibility Criteria
Inclusion
- Patients of age ≥ 45 years old
- Referred to colonoscopy for screening or surveillance colonoscopy (history of adenoma resection)
- The patient must understand and provide written consent for the procedure.
Exclusion
- Subjects with inflammatory bowel disease
- Subjects with a personal history of polyposis syndrome
- Subjects with suspected chronic stricture potentially precluding complete colonoscopy
- Subjects with diverticulitis or toxic megacolon
- Subjects with a history of radiation therapy to abdomen or pelvis
- Pregnant or lactating female subjects
- Subjects who are currently enrolled in another clinical investigation.
- Subjects with current oral or parenteral use of anticoagulants, not considered eligible by the investigator.
- Subjects with recent (within the last 3 mounts) coronary ischemia or CVA (stroke)
- Any patient condition deemed too risky for the study by the investigator
- Previous colonic surgery (except for appendectomy)
Key Trial Info
Start Date :
May 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2022
Estimated Enrollment :
2160 Patients enrolled
Trial Details
Trial ID
NCT05317351
Start Date
May 1 2022
End Date
December 1 2022
Last Update
April 7 2022
Active Locations (2)
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1
Indiana University
Indianapolis, Indiana, United States, 46202
2
NYU Langone Health
New York, New York, United States, 10016