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

Adenoma Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05317351
• Other study ID #: G-EYE15080
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 2022
• Est. completion date: December 2022

Study information

• Verified date: March 2022
• Source: Smart Medical Systems Ltd.
• Contact: Douglas K Rex, MD
• Phone: 317-777-9676
• Email: drex[@]iu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 2160
• Est. completion date: December 2022
• Est. primary completion date: December 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 45 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Adenoma
• Colorectal (Colon or Rectal) Cancer

Intervention

Device:
• Standard Colonoscopy
Subjects randomized into arm 1 will undergo standard colonoscopy using a standard colonoscope
• Artificial Intelligence Aided Colonoscopy (GI Genius™)
Subjects randomized into arm 2 will undergo colonoscopy using a standard colonoscope aided by Artificial Intelligence (GI Genius™)
• 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™).

Locations

Country	Name	City	State
United States	Indiana University	Indianapolis	Indiana
United States	NYU Langone Health	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Smart Medical Systems Ltd.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adenoma Per Colonoscopy (APC) (AI compared with AG)	Adenoma detection yield, represented by Adenoma Per Colonoscopy (APC) of AI compared with APC of AG.	Upon histology results (up to 30 days)
Secondary	Adenoma Per Colonoscopy (APC) (SC compared with AG)	Adenoma detection yield, represented by Adenoma Per Colonoscopy (APC) of SC compared with APC of AG	Upon histology results (up to 30 days)
Secondary	Advanced Adenoma Per Colonoscopy (AAPC) (SC compared with AG)	Advanced Adenoma detection yield, represented by Advanced Adenoma Per Colonoscopy (AAPC) of SC compared with AAPC of AG	Upon histology results (up to 30 days)