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Recruiting NCT07420309

Colonoscopy TRaining With or Without Artificial INtelligence Among Endoscopy Residents

No phase Interventional Colonoscopy Training

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Artificial Intelligence in colonoscopy, Conventional colonoscopy training.
Who it may be relevant to
Registry conditions: Colonoscopy Training. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Greece
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • Diagnostic test Artificial Intelligence in colonoscopy
    Training in colonoscopy with or without CADe
  • Diagnostic test Conventional colonoscopy training
    The trainees will be trained with the conventional colonoscopy for the study period

Primary outcome measures

  • Adenoma Miss Rate (AMR) at the end of the first year of training for each group and after the crossover. [Time frame: 3 months]
Secondary outcome measures (4)
  • Polyp Miss Rate (PMR) [Time frame: 3 months]
  • Adenoma Detection Rate (ADR) [Time frame: 3 months]
  • Polyp Detection Rate (PDR) [Time frame: 3 months]
  • Adverse events rate [Time frame: 3 months]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Crossover
Masking
Single blind
Primary purpose
Other

Study locations

Greece · 1 center
  • General University Hospital of Larissa — Larissa

Identifiers

NCT: NCT07420309 · 31637-23/07/2025

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗