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

S

Smart Medical Systems

Status

Not yet enrolling

Conditions

Colorectal (Colon or Rectal) Cancer
Adenoma

Treatments

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

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)

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

Trial contacts and locations

2

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Central trial contact

Douglas K Rex, MD

Data sourced from clinicaltrials.gov

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