Trials / Unknown
UnknownNCT05317351
A Prospective Randomized Study Comparing the Adenoma Detection Yield of SC, AI and Combined AI and G-EYE®
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
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 2,160 (estimated)
- Sponsor
- Smart Medical Systems Ltd. · Industry
- Sex
- All
- Age
- 45 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Standard Colonoscopy | Subjects randomized into arm 1 will undergo standard colonoscopy using a standard colonoscope |
| DEVICE | Artificial Intelligence Aided Colonoscopy (GI Genius™) | Subjects randomized into arm 2 will undergo colonoscopy using a standard colonoscope aided by Artificial Intelligence (GI Genius™) |
| DEVICE | Combined Artificial Intelligence Aided Colonoscopy (GI Genius™) and G-EYE® Balloon Aided Colonoscopy | Subjects enrolled to arm 3 ("AG") will undergo colonoscopy using the G-EYE® Colonoscope and Artificial Intelligence Aided Colonoscopy (GI Genius™). |
Timeline
- Start date
- 2022-05-01
- Primary completion
- 2022-12-01
- Completion
- 2022-12-01
- First posted
- 2022-04-07
- Last updated
- 2022-04-07
Locations
2 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT05317351. Inclusion in this directory is not an endorsement.