Comparison of Colonoscopy Adenoma Detection Yield

Helio's Health

Status: Unknown

Conditions: Adenoma Colon

Treatments: Device: Discovery and G-EYE; Device: Discovery aided colonoscopy; Device: Standard Colonoscopy

Study type: Interventional

Funder types: Industry

Identifiers

NCT05158725

G-EYE/Discovery

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,320 estimated patients

Sex: All

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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1,320 participants in 3 patient groups

Standard Colonoscopy

Active Comparator group

Description:

Subjects will undergo colonoscopy using a standard colonoscope

Treatment:

Device: Standard Colonoscopy

Discovery aided colonoscopy

Active Comparator group

Description:

Subjects will undergo colonoscopy using a a standard colonoscope and the Discovery aided colonoscopy

Treatment:

Device: Discovery aided colonoscopy

Discovery and G-EYE aided colonoscopy

Experimental group

Description:

Subjects will undergo colonoscopy using the G-EYE Endoscope and the Discovery aided colonoscopy

Treatment:

Device: Discovery and G-EYE