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

Not Applicable

• Conditions: Colo-rectal Cancer; Adenoma
• Interventions: Device: Standard Colonoscopy; Device: CAD-EYE; Device: G-EYE

• Registration Number: NCT05318495
• Lead Sponsor: Dr. Horst Schmidt Klinik GmbH

Brief 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.

Detailed 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

Study Timeline

• Study Start: 2022-03-01
• Study First Submitted: 2022-03-29
• Status Verified: 2022-04
• Study First Submitted QC: 2022-04-07
• Last Update Submitted: 2022-04-07
• Study First Posted: 2022-04-08
• Last Update Posted: 2022-04-08
• Primary Completion: 2022-12
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 372

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Standard Colonoscopy+CAD-EYE+G-EYE followed by Standard Colonoscopy	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. The Standard Colonoscope is a high-definition colonoscope employing advanced optical filtering and enhancement techniques - blue light imaging (BLI) and linked color imaging (LCI). 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.
Standard Colonoscopy followed by Standard Colonoscopy+CAD-EYE+G-EYE	Standard Colonoscopy	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. The Standard Colonoscope is a high-definition colonoscope employing advanced optical filtering and enhancement techniques - blue light imaging (BLI) and linked color imaging (LCI). 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.
Standard Colonoscopy+CAD-EYE+G-EYE followed by Standard Colonoscopy	G-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. The Standard Colonoscope is a high-definition colonoscope employing advanced optical filtering and enhancement techniques - blue light imaging (BLI) and linked color imaging (LCI). 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.
Standard Colonoscopy followed by Standard Colonoscopy+CAD-EYE+G-EYE	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. The Standard Colonoscope is a high-definition colonoscope employing advanced optical filtering and enhancement techniques - blue light imaging (BLI) and linked color imaging (LCI). 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.
Standard Colonoscopy followed by Standard Colonoscopy+CAD-EYE+G-EYE	G-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. The Standard Colonoscope is a high-definition colonoscope employing advanced optical filtering and enhancement techniques - blue light imaging (BLI) and linked color imaging (LCI). 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.
Standard Colonoscopy+CAD-EYE followed by Standard Colonoscopy	Standard Colonoscopy	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. The Standard Colonoscope is a high-definition colonoscope employing advanced optical filtering and enhancement techniques - blue light imaging (BLI) and linked color imaging (LCI).
Standard Colonoscopy followed by Standard Colonoscopy+CAD-EYE	Standard Colonoscopy	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. The Standard Colonoscope is a high-definition colonoscope employing advanced optical filtering and enhancement techniques - blue light imaging (BLI) and linked color imaging (LCI).
Standard Colonoscopy+CAD-EYE followed by Standard Colonoscopy	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. The Standard Colonoscope is a high-definition colonoscope employing advanced optical filtering and enhancement techniques - blue light imaging (BLI) and linked color imaging (LCI).
Standard Colonoscopy followed by Standard Colonoscopy+CAD-EYE	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. The Standard Colonoscope is a high-definition colonoscope employing advanced optical filtering and enhancement techniques - blue light imaging (BLI) and linked color imaging (LCI).
Standard Colonoscopy+CAD-EYE+G-EYE followed by Standard Colonoscopy	Standard Colonoscopy	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. The Standard Colonoscope is a high-definition colonoscope employing advanced optical filtering and enhancement techniques - blue light imaging (BLI) and linked color imaging (LCI). 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.

Primary Outcome Measures

Name	Time	Method
Additional adenoma detection yield	6 weeks	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

Trial Locations

Locations (1)

Helios Dr. Horst Schmidt Kliniken; 🇩🇪 Wiesbaden, Germany