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

Primary Purpose

Colorectal Cancer, Adenoma

Status

Recruiting

Phase

Not Applicable

Locations

Germany

Study Type

Interventional

Intervention

Standard Colonoscopy

G-EYE Colonoscopy

CAD-EYE

About this trial

This is an interventional screening trial for Colorectal Cancer focused on measuring G-EYE, Colonoscopy, CAD-EYE, Adenoma, Colorectal Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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 Criteria:

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

Sites / Locations

Helios Dr. Horst Schmidt Kliniken Wiesbaden GmbHRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Arm Label

Standard Colonoscopy followed by CAD-EYE

CAD-EYE followed by Standard Colonoscopy

Standard Colonoscopy followed by combined CAD-EYE and G-EYE colonoscopy

Combined CAD-EYE and G-EYE colonoscopy followed by Standard Colonoscopy

Arm Description

Subjects will undergo standard colonoscopy immediately followed by CAD-EYE colonoscopy (both procedures performed by the same endoscopist in the same sedation session).

Subjects will undergo CAD-EYE colonoscopy immediately followed by standard colonoscopy (both procedures performed by the same endoscopist in the same sedation session).

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).

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).

Outcomes

Primary Outcome Measures

Additional Adenoma Detection

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

Secondary Outcome Measures

Full Information

NCT ID

NCT05237310

First Posted

February 2, 2022

Last Updated

February 20, 2022

Sponsor

Smart Medical Systems Ltd.

Collaborators

Fujifilm

1. Study Identification

Unique Protocol Identification Number

NCT05237310

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2022

Overall Recruitment Status

Recruiting

Study Start Date

February 2, 2022 (Actual)

Primary Completion Date

August 2022 (Anticipated)

Study Completion Date

September 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Smart Medical Systems Ltd.

Collaborators

Fujifilm

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Colorectal Cancer, Adenoma

Keywords

G-EYE, Colonoscopy, CAD-EYE, Adenoma, Colorectal Cancer

7. Study Design

Primary Purpose

Screening

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Model Description

Subjects will be randomized to one of four groups (arms), Group A1, A2, B1 and B2: Group A1: Subjects will undergo standard colonoscopy immediately followed by CAD-EYE colonoscopy (both procedures performed by the same endoscopist in the same sedation session). Group A2: Subjects will undergo CAD-EYE colonoscopy immediately followed by standard colonoscopy (both procedures performed by the same endoscopist in the same sedation session). Group B1: 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). Group B2: 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).

Masking

None (Open Label)

Allocation

Randomized

Enrollment

372 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Standard Colonoscopy followed by CAD-EYE

Arm Type

Active Comparator

Arm Description

Subjects will undergo standard colonoscopy immediately followed by CAD-EYE colonoscopy (both procedures performed by the same endoscopist in the same sedation session).

Arm Title

CAD-EYE followed by Standard Colonoscopy

Arm Type

Active Comparator

Arm Description

Subjects will undergo CAD-EYE colonoscopy immediately followed by standard colonoscopy (both procedures performed by the same endoscopist in the same sedation session).

Arm Title

Standard Colonoscopy followed by combined CAD-EYE and G-EYE colonoscopy

Arm Type

Active Comparator

Arm Description

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).

Arm Title

Combined CAD-EYE and G-EYE colonoscopy followed by Standard Colonoscopy

Arm Type

Active Comparator

Arm Description

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).

Intervention Type

Device

Intervention Name(s)

Standard Colonoscopy

Intervention Description

Standard Colonoscopy using a standard Fujifilm colonoscope

Intervention Type

Device

Intervention Name(s)

G-EYE Colonoscopy

Intervention Description

G-EYE Colonoscopy performed using SMART Medical G-EYE Colonoscope

Intervention Type

Device

Intervention Name(s)

CAD-EYE

Intervention Description

Colonoscopy performed using with the aid of Fujifilm CAD-EYE artificial intelligence

Primary Outcome Measure Information:

Title

Additional Adenoma Detection

Description

Time Frame

Upon histology results (up to 30 days)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Criteria: 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Ralf Kiesslich, Prof.

Phone

+49 611 43-9002

Ralf.Kiesslich@helios-gesundheit.de

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ralf Kiesslich, Prof.

Organizational Affiliation

Helios Dr. Horst Schmidt Kliniken Wiesbaden GmbH

Official's Role

Principal Investigator

Facility Information:

Facility Name

Helios Dr. Horst Schmidt Kliniken Wiesbaden GmbH

City

Wiesbaden

ZIP/Postal Code

65199

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ralf Kiesslich, Prof.

Phone

+49 611 43-9002

Ralf.Kiesslich@helios-gesundheit.de

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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