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Clinical Trial NCT07420309 (c-TRAINER) for Colonoscopy Training is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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Colonoscopy TRaining With or Without Artificial INtelligence Among Endoscopy Residents (c-TRAINER) 10 Randomized Crossover Design

Recruiting
Clinical Trial NCT07420309 (c-TRAINER) is an interventional study for Colonoscopy Training that is recruiting. It started on February 1, 2026 with plans to enroll 10 participants. Led by University of Thessaly, it is expected to complete by July 1, 2027. The latest data from ClinicalTrials.gov was last updated on February 19, 2026.
Brief Summary
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.
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Official Title

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

Conditions
Colonoscopy Training
Other Study IDs
  • c-TRAINER
  • 31637-23/07/2025
NCT ID Number
NCT07420309
Start Date (Actual)
2026-02-01
Last Update Posted
2026-02-19
Completion Date (Estimated)
2027-07-01
Enrollment (Estimated)
10
Study Type
Interventional
PHASE
N/A
Status
Recruiting
Primary Purpose
Other
Design Allocation
Randomized
Interventional Model
Crossover Assignment
Masking
Single
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalCADe assisted colonoscopy
Trainees will be trained with the use of CADe
Artificial Intelligence in colonoscopy
Training in colonoscopy with or without CADe
Sham ComparatorConventional colonoscopy
Subjects will undergo training without AI for the study period
Conventional colonoscopy training
The trainees will be trained with the conventional colonoscopy for the study period
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime 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 MeasureMeasure DescriptionTime 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
Participation Assistant
Eligibility Criteria

Eligible Ages
Child, Adult, Older Adult
Eligible Sexes
All
Accepts Healthy Volunteers
Yes
  • 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.

  • 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)
University of Thessaly logoUniversity of Thessaly
Study Responsible Party
Apostolis Papaefthymiou, Principal Investigator, Assistant Professor, University of Thessaly
Study Central Contact
Contact: Apostolis Papaefthymiou, 00306973853042, [email protected]
1 Study Locations in 1 Countries
General University Hospital of Larissa, Larissa, Greece
Recruiting