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

NCT05318495 | Unknown

• 1 other identifier: Dual Tandem
• Study Type: interventional
• Target: 372
• Locations: 1 country
• Sites: 1

Brief Summary

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

1. 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. 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. 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.

Conditions

Adenoma; Colo-rectal Cancer

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (4)

Standard Colonoscopy+CAD-EYE followed by Standard Colonoscopy

EXPERIMENTAL

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; Device: CAD-EYE

Standard Colonoscopy followed by Standard Colonoscopy+CAD-EYE

ACTIVE COMPARATOR

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; Device: CAD-EYE

Standard Colonoscopy+CAD-EYE+G-EYE followed by Standard Colonoscopy

EXPERIMENTAL

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; Device: CAD-EYE; Device: G-EYE

Standard Colonoscopy followed by Standard Colonoscopy+CAD-EYE+G-EYE

ACTIVE COMPARATOR

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; Device: CAD-EYE; Device: G-EYE

Interventions

Standard Colonoscopy DEVICE

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 followed by Standard Colonoscopy+CAD-EYE+G-EYE; Standard Colonoscopy+CAD-EYE followed by Standard Colonoscopy; Standard Colonoscopy+CAD-EYE+G-EYE followed by Standard Colonoscopy

CAD-EYE DEVICE

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.

Standard Colonoscopy followed by Standard Colonoscopy+CAD-EYE; Standard Colonoscopy followed by Standard Colonoscopy+CAD-EYE+G-EYE; Standard Colonoscopy+CAD-EYE followed by Standard Colonoscopy; Standard Colonoscopy+CAD-EYE+G-EYE followed by Standard Colonoscopy

G-EYE DEVICE

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+G-EYE followed by Standard Colonoscopy

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Screening and surveillance population for Adenoma and CRC.
• The patient must understand and sign a written informed consent for the procedure.

You may not qualify if:

• 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 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

Sponsors & Collaborators

• Dr. Horst Schmidt Klinik GmbH: lead

Study Sites (1)

Helios Dr. Horst Schmidt Kliniken

Wiesbaden, 65199, Germany

RECRUITING

MeSH Terms

Conditions

Adenoma; Colonic Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Ralf Kiesslich, Prof.

  Helios Dr. Horst Schmidt Kliniken Wiesbaden

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ralf Kiesslich, Prof.

CONTACT

49-611432421; Ralf.Kiesslich@helios-gesundheit.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: March 29, 2022
• First Posted: April 8, 2022
• Study Start: March 1, 2022
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: April 8, 2022

Record last verified: 2022-04

Locations

DE (1)