A Dual Tandem Study - SC vs. CAD-EYE vs. CAD-EYE With G-EYE

Colo-rectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05318495
• Other study ID #: Dual Tandem
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2022
• Est. completion date: December 2022

Study information

• Verified date: April 2022
• Source: Dr. Horst Schmidt Klinik GmbH
• Contact: Ralf Kiesslich, Prof.
• Phone: 49-611432421
• Email: Ralf.Kiesslich[@]helios-gesundheit.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Single-center, four-arm dual-tandem, randomized, open-label study involving the following devices:

1. The Standard Colonoscope is a high-definition colonoscope employing advanced optical filtering and enhancement techniques - blue light imaging (BLI) and linked color imaging (LCI).

2. CAD-EYE is an artificial intelligence software, used in real-time during the colonoscopy procedure for aiding the identification and characterization of polyps and adenomas.

3. The G-EYE® balloon is a reusable (reprocessable) balloon permanently installed on the distal tip of a standard colonoscope, and is also intended to assist in flattening colonic folds and control the colonoscope's field of view and tip positioning.

Description:

Single-center, four-arm dual-tandem, randomized, open-label study involving the following devices:

1. The Standard Colonoscope is a high-definition colonoscope employing advanced optical filtering and enhancement techniques - blue light imaging (BLI) and linked color imaging (LCI).

2. CAD-EYE is an artificial intelligence software, used in real-time during the colonoscopy procedure for aiding the identification and characterization of polyps and adenomas.

3. The G-EYE® balloon is a reusable (reprocessable) balloon permanently installed on the distal tip of a standard colonoscope, and is also intended to assist in flattening colonic folds and control the colonoscope's field of view and tip positioning.

Total of up to 372 patients will be randomized,186 to each of the two tandems

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 372
• Est. completion date: December 2022
• Est. primary completion date: December 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

1. Screening and surveillance population for Adenoma and CRC.

2. 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

Related Conditions & MeSH terms

• Adenoma
• Colo-rectal Cancer

Intervention

Device:
• Standard Colonoscopy
The Standard Colonoscope is a high-definition colonoscope employing advanced optical filtering and enhancement techniques - blue light imaging (BLI) and linked color imaging (LCI).
• CAD-EYE
CAD-EYE is an artificial intelligence software, used in real-time during the colonoscopy procedure for aiding the identification and characterization of polyps and adenomas.
• G-EYE
The G-EYE® balloon is a reusable (reprocessable) balloon permanently installed on the distal tip of a standard colonoscope, and is also intended to assist in flattening colonic folds and control the colonoscope's field of view and tip positioning.

Locations

Country	Name	City	State
Germany	Helios Dr. Horst Schmidt Kliniken	Wiesbaden

Sponsors (1)

Lead Sponsor	Collaborator
Dr. Horst Schmidt Klinik GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Additional adenoma detection yield	additional adenoma detection yield (represented by the miss rate) of CAD-EYE and G-EYE® colonoscopy over standard coloscopy compared to the additional adenoma detection yield of CAD-EYE aided colonoscopy over standard colonoscopy	6 weeks