Comparison of Colonoscopy Adenoma Detection Yield

Not Applicable

• Conditions: Adenoma Colon
• Interventions: Device: Discovery aided colonoscopy; Device: Standard Colonoscopy; Device: Discovery and G-EYE

• Registration Number: NCT05158725
• Lead Sponsor: Dr. Horst Schmidt Klinik GmbH

Brief 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.

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 Timeline

• Study Start: 2021-11-08
• Status Verified: 2021-12
• Study First Submitted: 2021-12-02
• Study First Submitted QC: 2021-12-02
• Last Update Submitted: 2021-12-02
• Study First Posted: 2021-12-15
• Last Update Posted: 2021-12-15
• Primary Completion: 2022-05
• Study Completion: 2022-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1320

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Discovery aided colonoscopy	Discovery aided colonoscopy	Subjects will undergo colonoscopy using a a standard colonoscope and the Discovery aided colonoscopy
Standard Colonoscopy	Standard Colonoscopy	Subjects will undergo colonoscopy using a standard colonoscope
Discovery and G-EYE aided colonoscopy	Discovery and G-EYE	Subjects will undergo colonoscopy using the G-EYE Endoscope and the Discovery aided colonoscopy

Primary Outcome Measures

Name	Time	Method
Adenoma detection yield	Upon histology results (up to 30 days)	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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Helios Dr. Horst Schmidt Kliniken Wiesbaden GmbH; 🇩🇪 Wiesbaden, Germany