Comparison of Colonoscopy Adenoma Detection Yield

Comparison of Colonoscopy Adenoma Detection Yield of Standard Colonoscopy, Discovery Aided Colonoscopy, and Discovery and G-EYE® Aided Colonoscopy

A Prospective Randomized Comparison of colonoscopy Adenoma Detection Yield of (i) Standard Colonoscopy (SC), (ii) artificial intelligence (Discovery) aided colonoscopy, and (iii) artificial intelligence (Discovery) and permanently mounted balloon (G-EYE®) aided colonoscopy.

Study Overview

• Status: Recruiting
• Conditions: Adenoma Colon
• Intervention / Treatment: Device: Standard Colonoscopy; Device: Discovery aided colonoscopy; Device: Discovery and G-EYE

Detailed Description

Multi-center, three-arm, randomized, controlled, open-label study.

Total of up to 1320 patients will be randomized, including up to 10% for subject drop-out, 440 to each of the three following arms (groups):

Group 1 (1st arm): patients will receive standard colonoscopy (SC) Group 2 (2nd arm): patients will receive colonoscopy aided by the Discovery artificial intelligence software (DC) Group 3 (3rd arm): patients will receive colonoscopy aided by the Discovery artificial intelligence software and the G-EYE® balloon (GDC) The purpose of this study is to compare between the diagnostic yield of Standard Colonoscopy, Discovery aided colonoscopy, and Discovery & G-EYE® aided colonoscopy.

• Study Type: Interventional
• Enrollment (Anticipated): 1320
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ralf Kiesslich, Prof.; Phone Number: +49 611 43-9002; Email: Ralf.Kiesslich@helios-gesundheit.de

Study Locations

• Germany
  • Wiesbaden, Germany, 65199
    • Recruiting
    • Helios Dr. Horst Schmidt Kliniken Wiesbaden GmbH
    • Contact: Ralf Kiesslich, Prof.; Phone Number: +49 611 43-9002; 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

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard Colonoscopy; Subjects will undergo colonoscopy using a standard colonoscope	Device: Standard Colonoscopy; In this arm, subjects will undergo colonoscopy using a standard colonoscope
Active Comparator: Discovery aided colonoscopy; Subjects will undergo colonoscopy using a a standard colonoscope and the Discovery aided colonoscopy	Device: Discovery aided colonoscopy; the Discovery is a customized detection support software, developed utilizing AI deep learning technology to support endoscopic lesion detection in the colon. In this arm, a standard colonoscope is used with the Discovery.
Experimental: Discovery and G-EYE aided colonoscopy; Subjects will undergo colonoscopy using the G-EYE Endoscope and the Discovery aided colonoscopy	Device: Discovery and G-EYE; The G-EYE® Endoscope is a standard colonoscope which is remanufactured by installing the G-EYE® balloon on the distal bending section of the colonoscope. in this arm, the G-EYE® Endoscope is used with the Discovery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adenoma detection yield	adenoma detection yield, represented by Adenoma Per Colonoscopy (APC), of Standard Colonoscopy, compared with APC of Discovery aided colonoscopy and further compared with APC of Discovery & G-EYE® aided colonoscopy	Upon histology results (up to 30 days)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adenoma Detection Rate (Discovery + G-EYE vs. Standard Colonoscopy)	Adenoma Detection Rate of Discovery and G-EYE® aided colonoscopy compared to Adenoma Detection Rate of Standard Colonoscopy	Upon histology results (up to 30 days)
Adenoma Detection Rate (Discovery vs. Standard Colonosocopy)	Adenoma Detection Rate of Discovery aided colonoscopy compared to Adenoma Detection Rate of Standard Colonoscopy	Upon histology results (up to 30 days)
Adenoma Per Colonoscopy (Discovery vs. Discovery + G-EYE)	Adenoma Per Colonoscopy of Discovery aided colonoscopy compared to Adenoma Per Colonoscopy of Discovery and G-EYE® aided colonoscopy	Upon histology results (up to 30 days)

Collaborators and Investigators

• Sponsor: Dr. Horst Schmidt Klinik GmbH
• Investigators: Principal Investigator: Ralf Kiesslich, Prof., Helios Dr. Horst Schmidt Kliniken Wiesbaden GmbH

Study record dates

Study Major Dates

• Study Start (Actual): November 8, 2021
• Primary Completion (Anticipated): May 1, 2022
• Study Completion (Anticipated): June 1, 2022

Study Registration Dates

• First Submitted: December 2, 2021
• First Submitted That Met QC Criteria: December 2, 2021
• First Posted (Actual): December 15, 2021

Study Record Updates

• Last Update Posted (Actual): December 15, 2021
• Last Update Submitted That Met QC Criteria: December 2, 2021
• Last Verified: December 1, 2021

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: G-EYE/Discovery

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

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