A Prospective Randomized Study Comparing the Adenoma Detection Yield of SC, AI and Combined AI and G-EYE®

Smart Medical Systems

Status: Unknown

Conditions: Colorectal (Colon or Rectal) Cancer; Adenoma

Treatments: Device: Combined Artificial Intelligence Aided Colonoscopy (GI Genius™) and G-EYE® Balloon Aided Colonoscopy; Device: Standard Colonoscopy; Device: Artificial Intelligence Aided Colonoscopy (GI Genius™)

Study type: Interventional

Funder types: Industry

Identifiers

NCT05317351

G-EYE15080

Details and patient eligibility

About

This is a multicenter, 3-arm, randomized, open-label study. Subjects referred to colonoscopy for screening or surveillance will be randomized in a 2:5:5 into one of the following arms:

(i) Standard Colonoscopy (ii) Artificial Intelligence Aided Colonoscopy (GI Genius™) (iii) Combined Artificial Intelligence Aided Colonoscopy (GI Genius™) and G-EYE® Balloon Aided Colonoscopy

Full description

This is a multicenter, 3-arm, randomized, open-label study. Subjects referred to colonoscopy for screening or surveillance will be randomized in a 2:5:5 into one of the following arms:

(i) Standard Colonoscopy (ii) Artificial Intelligence Aided Colonoscopy (GI Genius™) (iii) Combined Artificial Intelligence Aided Colonoscopy (GI Genius™) and G-EYE® Balloon Aided Colonoscopy Study aim is to compare the adenoma detection yield, expressed by Adenoma Per Colonoscopy (APC), of these 3 arms.

Enrollment: 2,160 estimated patients

Sex: All

Ages: 45+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Patients of age ≥ 45 years old
2. Referred to colonoscopy for screening or surveillance colonoscopy (history of adenoma resection)
3. The patient must understand and provide written consent for the procedure.

Exclusion criteria

1. Subjects with inflammatory bowel disease
2. Subjects with a personal history of polyposis syndrome
3. Subjects with suspected chronic stricture potentially precluding complete colonoscopy
4. Subjects with diverticulitis or toxic megacolon
5. Subjects with a history of radiation therapy to abdomen or pelvis
6. Pregnant or lactating female subjects
7. Subjects who are currently enrolled in another clinical investigation.
8. Subjects with current oral or parenteral use of anticoagulants, not considered eligible by the investigator.
9. Subjects with recent (within the last 3 mounts) coronary ischemia or CVA (stroke)
10. Any patient condition deemed too risky for the study by the investigator
11. Previous colonic surgery (except for appendectomy)

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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2,160 participants in 3 patient groups

Standard Colonoscopy ("SC")

Active Comparator group

Description:

Subjects enrolled to arm 1 ("SC") will undergo colonoscopy using a standard colonoscope.

Treatment:

Device: Standard Colonoscopy

Artificial Intelligence Aided Colonoscopy (GI Genius™) ("AI")

Active Comparator group

Description:

Subjects enrolled to arm 2 ("AI") will undergo colonoscopy using a standard colonoscope aided by Artificial Intelligence (GI Genius™)

Treatment:

Device: Artificial Intelligence Aided Colonoscopy (GI Genius™)

Combined Artificial Intelligence (GI Genius™) and G-EYE® Colonoscopy (AG)

Experimental group

Description:

Subjects enrolled to arm 3 ("AG") will undergo colonoscopy using the G-EYE® Colonoscope and Artificial Intelligence Aided Colonoscopy (GI Genius™).

Treatment:

Device: Combined Artificial Intelligence Aided Colonoscopy (GI Genius™) and G-EYE® Balloon Aided Colonoscopy