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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05158725
Other study ID # G-EYE/Discovery
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date November 8, 2021
Est. completion date June 2022

Study information

Verified date December 2021
Source Dr. Horst Schmidt Klinik GmbH
Contact Ralf Kiesslich, Prof.
Phone +49 611 43-9002
Email Ralf.Kiesslich@helios-gesundheit.de
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 1320
Est. completion date June 2022
Est. primary completion date May 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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Standard Colonoscopy
In this arm, subjects will undergo colonoscopy using a standard colonoscope
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.
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

Locations

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