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

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.

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.

Study Overview

• Status: Recruiting
• Conditions: Adenoma; Colo-rectal Cancer
• Intervention / Treatment: Device: Standard Colonoscopy; Device: CAD-EYE; Device: G-EYE

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 Type: Interventional
• Enrollment (Anticipated): 372
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ralf Kiesslich, Prof.; Phone Number: 49-611432421; Email: ralf.kiesslich@helios-gesundheit.de

Study Locations

• Germany
  • Wiesbaden, Germany, 65199
    • Recruiting
    • Helios Dr. Horst Schmidt Kliniken
    • Contact: Ralf Kiesslich, Prof.; Phone Number: 49-611432421; Email: ralf.kiesslich@helios-gesundheit.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; 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. 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

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Standard Colonoscopy+CAD-EYE followed by 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).	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).; Device: 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.
Active Comparator: Standard Colonoscopy 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).	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).; Device: 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.
Experimental: Standard Colonoscopy+CAD-EYE+G-EYE followed by 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.	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).; Device: 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.; Device: 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.
Active Comparator: Standard Colonoscopy followed by Standard Colonoscopy+CAD-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.	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).; Device: 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.; Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Dr. Horst Schmidt Klinik GmbH

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2022
• Primary Completion (Anticipated): December 1, 2022
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: March 29, 2022
• First Submitted That Met QC Criteria: April 7, 2022
• First Posted (Actual): April 8, 2022

Study Record Updates

• Last Update Posted (Actual): April 8, 2022
• Last Update Submitted That Met QC Criteria: April 7, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Adenoma
• Other Study ID Numbers: Dual Tandem

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No