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Recruiting

NCT Number: NCT07420309

Colonoscopy TRaining With or Without Artificial INtelligence Among Endoscopy Residents

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.

Recruiting

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Key information

Conditions

Colonoscopy Training

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

General University Hospital of Larissa

Larissa, Greece

Location status: Recruiting

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

  • Provision of signed and dated informed consent form understand the risks and benefits of the study
  • Aged ≥18 years old
  • Able to read and write in the provided language.
  • 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:

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

Treatment and study plan

Artificial Intelligence in colonoscopy

Diagnostic Test

Training in colonoscopy with or without CADe

Conventional colonoscopy training

Diagnostic Test

The trainees will be trained with the conventional colonoscopy for the study period

Primary outcomes

  1. Adenoma Miss Rate (AMR) at the end of the first year of training for each group and after the crossover.

    Time frame: 3 months

    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.

Secondary outcomes

  1. Polyp Miss Rate (PMR)

    Time frame: 3 months

    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.

  2. Adenoma Detection Rate (ADR)

    Time frame: 3 months

    ADR is defined as the proportion of individuals who have at least one histologically confirmed conventional adenoma.

  3. Polyp Detection Rate (PDR)

    Time frame: 3 months

    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).

  4. Adverse events rate

    Time frame: 3 months

    Adverse events defined by the ASGE lexicon

Study contacts

Contact information is provided by the study sponsor or research team.

Apostolis Papaefthymiou

CONTACT

[email protected]

00306973853042

Sponsors and collaborators

Lead sponsor

University of Thessaly

Other

Registry information

Official study title

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

Acronym: c-TRAINER

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Feb 19, 2026
Registry last updated
Feb 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.