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

February 20, 2022 updated by: Smart Medical Systems Ltd.

Dual Tandem Study Comparing the Adenoma Detection and Miss-rate of Standard Colonoscopy to That of Artificial Intelligence (CAD-EYE) and to That of Artificial Intelligence (CAD-EYE) and G-EYE® Aided Colonoscopy

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Anticipated)

372

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Standard Colonoscopy followed by CAD-EYE
Subjects will undergo standard colonoscopy immediately followed by CAD-EYE colonoscopy (both procedures performed by the same endoscopist in the same sedation session).
Device: Standard Colonoscopy
Standard Colonoscopy using a standard Fujifilm colonoscope
Device: CAD-EYE
Colonoscopy performed using with the aid of Fujifilm CAD-EYE artificial intelligence
Active Comparator: CAD-EYE followed by Standard Colonoscopy
Subjects will undergo CAD-EYE colonoscopy immediately followed by standard colonoscopy (both procedures performed by the same endoscopist in the same sedation session).
Device: Standard Colonoscopy
Standard Colonoscopy using a standard Fujifilm colonoscope
Device: CAD-EYE
Colonoscopy performed using with the aid of Fujifilm CAD-EYE artificial intelligence
Active Comparator: Standard Colonoscopy followed by combined CAD-EYE and G-EYE colonoscopy
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).
Device: Standard Colonoscopy
Standard Colonoscopy using a standard Fujifilm colonoscope
Device: CAD-EYE
Colonoscopy performed using with the aid of Fujifilm CAD-EYE artificial intelligence
Device: G-EYE Colonoscopy
G-EYE Colonoscopy performed using SMART Medical G-EYE Colonoscope
Active Comparator: Combined CAD-EYE and G-EYE colonoscopy followed by Standard Colonoscopy
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).
Device: Standard Colonoscopy
Standard Colonoscopy using a standard Fujifilm colonoscope
Device: CAD-EYE
Colonoscopy performed using with the aid of Fujifilm CAD-EYE artificial intelligence
Device: G-EYE Colonoscopy
G-EYE Colonoscopy performed using SMART Medical G-EYE Colonoscope

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Additional Adenoma Detection
Time Frame: 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
Upon histology results (up to 30 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Smart Medical Systems Ltd.

Collaborators

Fujifilm

Investigators

  • Principal Investigator: Ralf Kiesslich, Prof., Helios Dr. Horst Schmidt Kliniken Wiesbaden GmbH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 2, 2022

Primary Completion (Anticipated)

August 1, 2022

Study Completion (Anticipated)

September 1, 2022

Study Registration Dates

First Submitted

February 2, 2022

First Submitted That Met QC Criteria

February 2, 2022

First Posted (Actual)

February 14, 2022

Study Record Updates

Last Update Posted (Actual)

March 8, 2022

Last Update Submitted That Met QC Criteria

February 20, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • G-EYE 15076

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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