AI_Colonoscopy_for_Fellows

NCT07661914 | Active Not Recruiting FDA Device

• 1 other identifier: 18531
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to look at how good artificial intelligence (AI) assisted colonoscopy is compared to conventional colonoscopy in detecting polyps when used by gastroenterology fellows. The main question the study aims to answer are: Does AI assisted colonoscopy improve adenoma detection rate for gastroenterology fellows in different levels of training? Does AI assisted colonoscopy improve other quality indicators such as sessile serrated lesion detection rate withdrawal time? This research will compare these quality measures for gastroenterology fellows in their first, second, and third year of training. The gastroenterology fellows performing colonoscopies will be randomized to either AI assisted colonoscopy or conventional colonoscopy for each case. The nurse in the room will then turn on the AI device if needed and the rest of the colonoscopy will be completed as normal. The procedure notes will indicated whether AI device was used or not during the procedure.

Conditions

AI-assisted Colonoscopy

Keywords

AI assisted colonoscopy; GI Genius

Outcome Measures

Primary Outcomes (1)

• Adenoma detection rate

  We hypothesize that an AI assisted colonoscopy done by a gastroenterology fellow will have a higher ADR as compared to conventional colonoscopy done by the same fellow and these results will be more significant among junior fellows compared to senior fellows.

  over 18 months

Secondary Outcomes (2)

• Sessile serrated lesion detection rate

  Over 18 months

• Withdrawal time

  Over 18 months

Study Arms (2)

AI assisted colonoscopy

EXPERIMENTAL

GI fellows in this arm will complete colonoscopies with the assistance of AI device GI Genius.

Device: AI assisted colonoscopy

Conventional colonoscopy

ACTIVE COMPARATOR

GI fellows in this arm will complete colonoscopy in a conventional manner

Other: Conventional Colonoscopy

Interventions

AI assisted colonoscopy DEVICE

The gastroenterology fellows assigned to AI assisted colonoscopy will use the GI genius device while performing colonoscopies.

AI assisted colonoscopy

Conventional Colonoscopy OTHER

The gastroenterology fellows assigned to conventional colonoscopy will be performing colonoscopies without the use of AI device.

Conventional colonoscopy

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• All adult gastroenterology fellows at the University of Oklahoma, except for the fellow conducting research will be included in the study.

You may not qualify if:

• All patients undergoing colonoscopy for genetic cancer syndromes (ex: polyposis), inflammatory bowel disease, for therapy of known neoplasms or undergoing non-colonoscopy screening tests (fecal immunochemical test, CT colonography) will be excluded from this study.

Sponsors & Collaborators

• University of Oklahoma: lead
• Oklahoma City VA Medical Center: collaborator

Study Sites (1)

Oklahoma City VA Health Care System

Oklahoma City, Oklahoma, 73104, United States

Location

Study Officials

• Mohammad Madhoun

  University of Oklahoma

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: In this study each gastroenterology fellow will be randomized to either AI assisted colonoscopy arm vs conventional colonoscopy for each case. Thus each fellow will function as his or her own control.

Study Record Dates

• First Submitted: June 9, 2026
• First Posted: June 22, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): March 30, 2027
• Study Completion (Estimated): July 30, 2027
• Last Updated: June 22, 2026

Record last verified: 2026-06

Locations

US (1)