Colonoscopy TRaining With or Without Artificial INtelligence Among Endoscopy Residents (c-TRAINER)

Colonoscopy Training With or Without Artificial Intelligence Among Endoscopy Residents: a Randomized Controlled Study

Type of study: Randomized controlled study

Investigated Procedure: Artificial Intelligence Software for Polyp Detection in Colonoscopy training

Trial participants: Endoscopy trainees during their training with at least one year of training ahead and no previous structured exposure to CADe

Objectives:

Primary: Adenoma Miss Rate (AMR) in the end of the first year of training for each group and after the crossover.

Secondary: Further endoscopists-related parameters will be recorded and compared between the two arms: PDR, ADR, aADR, PMR, withdrawal time, CIR, AEs

The investigators will be asked, when possible, to follow-up the patients until they have their next colonoscopy or a diagnosis of CRC to assess for interval cancer.

Study Overview

• Status: Recruiting
• Conditions: Colonoscopy Training
• Intervention / Treatment: Diagnostic test: Artificial Intelligence in colonoscopy; Diagnostic test: Conventional colonoscopy training

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Apostolis Papaefthymiou; Phone Number: 00306973853042; Email: appapaefthymiou@uth.gr

Study Locations

• Greece
  • Larissa, Greece
    • Recruiting
    • General University Hospital Of Larissa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Trial participants: Endoscopy trainees at any time of their training, with at least one year of training ahead without previous structured exposure to CADe during their training.

Recruited patient population: Adult patients undergoing diagnostic, screening, or surveillance colonoscopy will be included.

1. Provision of signed and dated informed consent form understand the risks and benefits of the study
2. Aged ≥18 years old
3. Able to read and write in the provided language.
4. Participants capable to provide written informed consent and comply with the trial protocol.

Exclusion Criteria:

• Trial participants: Endoscopy trainees after their basic training, during the last year of training or with systematic exposure to CADe.

Recruited patient population:

1. Patients with a known contraindication for biopsy, bowel obstruction or perforation,
2. Pregnant or lactating females
3. Known polyposis syndromes, or who had a history of inflammatory bowel disease (IBD), CRC, or colorectal surgery.
4. Any patient whose cecum is not reached and who were highly suspected of having polyposis syndromes, IBD, intestinal tuberculosis, or CRC.
5. Incomplete bowel preparation (segmental Boston Bowel Preparation Score <2, or total <6)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CADe assisted colonoscopy; Trainees will be trained with the use of CADe	Diagnostic test: Artificial Intelligence in colonoscopy; Training in colonoscopy with or without CADe
Sham Comparator: Conventional colonoscopy; Subjects will undergo training without AI for the study period	Diagnostic test: Conventional colonoscopy training; The trainees will be trained with the conventional colonoscopy for the study period

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adenoma Miss Rate (AMR) at the end of the first year of training for each group and after the crossover.	AMR is defined as the number of adenomas detected in the by each trainee divided by the total number of adenomas detected by the respective supervising expert.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Polyp Miss Rate (PMR)	PMR is defined as the number of polyps detected in the by each trainee divided by the total number of polyps detected by the respective supervising expert.	3 months
Adenoma Detection Rate (ADR)	ADR is defined as the proportion of individuals who have at least one histologically confirmed conventional adenoma.	3 months
Polyp Detection Rate (PDR)	PDR is defined as the proportion of individuals who have at least one polyp detected during a complete screening colonoscopy and can be readily calculated based on pathology report (including adenoma, serrated sessile lesions, and inflammatory and hyperplastic polyp).	3 months
Adverse events rate	Adverse events defined by the ASGE lexicon	3 months

Collaborators and Investigators

• Sponsor: University of Thessaly

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): July 1, 2027

Study Registration Dates

• First Submitted: January 13, 2026
• First Submitted That Met QC Criteria: February 11, 2026
• First Posted (Actual): February 19, 2026

Study Record Updates

• Last Update Posted (Actual): February 19, 2026
• Last Update Submitted That Met QC Criteria: February 11, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Diagnostic Techniques and Procedures; Diagnosis; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Diagnostic Techniques, Surgical; Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Endoscopy; Digestive System Surgical Procedures; Algorithms; Mathematical Concepts; Colonoscopy; Artificial Intelligence
• Other Study ID Numbers: 31637-23/07/2025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No