Comparison of Colonoscopy Adenoma Detection Yield

Adenoma Colon Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05158725
• Other study ID #: G-EYE/Discovery
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Adenoma
• Adenoma Colon

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)