Recruiting

Observational Study

Sponsor:

Northwestern University

Code:

NCT06676930

Conditions

Colon Polyps

Colonoscopy

Artificial Intelligence (AI)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Colonoscopy With Computer-Aided Detection

Colonoscopy without Computer-Aided Detection

Study Details

Brief summary:

Based on prior studies, trainee and practicing gastroenterologists miss pre-cancerous polyps (adenomas and serrated polyps) during colonoscopy. The use of computer-aided detection (CADe) systems, a form of artificial intelligence (AI) has been shown to help identify colorectal lesions for practicing gastroenterologists. However, less is known how AI impacts polyp detection for trainees.

The investigators are conducting a tandem colonoscopy study wherein a portion of the colon is examined first by the trainee and then the attending physician. For each procedure, randomization will occur which will determine whether or not the trainee will utilize AI for their examination of the colon. At the end of the study, the investigators will determine whether AI helps trainees miss fewer polyps during colonoscopy. The investigators will also conduct interviews with trainees to understand how AI impacts colonoscopy training.

Conditions

Colon Polyps

Colonoscopy

Artificial Intelligence (AI)

Study ID

NCT06676930

Start date

Sep 10, 2024

Status verified date

Nov, 2024

Completion date

Sep, 2026

Anticipated

Primary completion date

Dec, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Adult patients referred for screening or surveillance colonoscopy

Exclusion Criteria:

  • Patients referred for polypectomy or diagnostic colonoscopy
  • Patients with prior right colon surgery
  • Prolonged insertion time (>20 minutes)
  • Poor bowel preparation (Boston Bowel Preparation Score less than or equal to 6)

Study Design

Enrollment

180 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

active comparator: Colonoscopy with AI

Trainee using AI during colonoscopy inspection

active comparator: Colonoscopy without AI

Trainee not using AI during colonoscopy inspection

Interventions

Colonoscopy With Computer-Aided Detection

Use of Computer-Aided Detection During Colonoscopy

Colonoscopy without Computer-Aided Detection

Colonoscopy without Computer-Aided Detection (AI)

Primary outcome measure

  • Neoplastic polyp miss rate [ Time Frame: 1 week ]

Central Contacts and Locations

Locations

Northwestern Memorial Hospital

Recruiting

Chicago, Illinois, United States, 60611

Contacts

More Information

Sponsor

Northwestern University

Last update posted

Nov 6, 2024

Last verified

Nov, 2024

Keywords

  • tandem colonoscopy
  • randomized controlled trial
  • adenoma miss rate

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Northwestern University on 2024-11-06.