Comparing Detection of Standard Colonoscopy, CAD-EYE and Combined CAD-EYE and G-EYE® Aided Colonoscopy

Last updated: February 20, 2022
Sponsor: Smart Medical Systems Ltd.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Colorectal Cancer

Colon Cancer; Rectal Cancer

Rectal Cancer

Treatment

N/A

Clinical Study ID

NCT05237310
G-EYE 15076
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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

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 consideredeligible 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

Study Design

Total Participants: 372
Study Start date:
February 02, 2022
Estimated Completion Date:
September 30, 2022

Study 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

Connect with a study center

  • Helios Dr. Horst Schmidt Kliniken Wiesbaden GmbH

    Wiesbaden, 65199
    Germany

    Active - Recruiting

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