Status:
UNKNOWN
Comparing Detection of Standard Colonoscopy, CAD-EYE and Combined CAD-EYE and G-EYE® Aided Colonoscopy
Lead Sponsor:
Smart Medical Systems Ltd.
Collaborating Sponsors:
Fujifilm
Conditions:
Colorectal Cancer
Adenoma
Eligibility:
All Genders
18+ years
Phase:
NA
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...
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...
Eligibility Criteria
Inclusion
- Screening and surveillance population for Adenoma and CRC.
- Subjects age is at least 18 years
- The patient must understand and sign a written informed consent for the procedure.
Exclusion
- Subjects with inflammatory bowel disease;
- Subjects with a personal history of hereditary polyposis syndrome;
- Subjects with suspected chronic stricture potentially precluding complete colonoscopy;
- Subjects with diverticulitis or toxic megacolon;
- Subjects with prior colonic surgery (exclusion appendectomy)
- 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
Key Trial Info
Start Date :
February 2 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2022
Estimated Enrollment :
372 Patients enrolled
Trial Details
Trial ID
NCT05237310
Start Date
February 2 2022
End Date
September 1 2022
Last Update
March 8 2022
Active Locations (1)
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1
Helios Dr. Horst Schmidt Kliniken Wiesbaden GmbH
Wiesbaden, Germany, 65199