Clinical trial NCT05317351: A Prospective Randomized Study Comparing the Adenoma Detection Yield of SC, AI and Combined AI and G-EYE®
Official title: A Prospective Randomized Study Comparing the Adenoma Detection Yield of (i) Standard Colonoscopy ("SC"), (ii) Artificial Intelligence (GI Genius™) ("AI"), and (Iii) Combined Artificial Intelligence (GI Genius™) and G-EYE® Colonoscopy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Colorectal (Colon or Rectal) Cancer
Adenoma
Lead sponsor: Smart Medical Systems Ltd.
Sponsor class: INDUSTRY
First posted: 2022-04-07
Enrollment: 2160
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model 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™), and (iii) Combined Artificial Intelligence Aided Colonoscopy (GI Genius™) and G-EYE® Balloon Aided Colonoscopy
Primary purpose: SCREENING

Brief summary: 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

Detailed 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Adenoma Per Colonoscopy (APC) (AI compared with AG)
timeFrame: Upon histology results (up to 30 days)
Secondary outcomes:
measure: Adenoma Per Colonoscopy (APC) (SC compared with AG)
timeFrame: Upon histology results (up to 30 days)
measure: Advanced Adenoma Per Colonoscopy (AAPC) (SC compared with AG)
timeFrame: Upon histology results (up to 30 days)
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: Indina University
name: Douglad K Rex, MD
role: PRINCIPAL_INVESTIGATOR
References: