Colonoscopy Trainingc-TRAINERNCT07420309
Colonoscopy TRaining With or Without Artificial INtelligence Among Endoscopy Residents
A study testing Artificial Intelligence in colonoscopy and Conventional colonoscopy training in people with Colonoscopy Training, run by University of Thessaly at 1 site in Greece.
Trial 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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Colonoscopy Training
- What is being tested?
- Artificial Intelligence in colonoscopy and Conventional colonoscopy training
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteGreece
- Study dates
- 1 Feb 2026to 1 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Greece1 site, 1 recruiting
- Recruiting
General University Hospital of Larissa
Larissa
About this study
Official title: 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
Read more
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.
- Conditions
- Colonoscopy Training
- Being tested
- Artificial Intelligence in colonoscopy, Conventional colonoscopy training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Artificial Intelligence in colonoscopyDiagnostic test
Training in colonoscopy with or without CADe
Conventional colonoscopy trainingDiagnostic test
The trainees will be trained with the conventional colonoscopy for the study period
| Study group | Role | What they receive |
|---|---|---|
| CADe assisted colonoscopy | Experimental | Trainees will be trained with the use of CADe Receives: Diagnostic Test: Artificial Intelligence in colonoscopy |
| Conventional colonoscopy | Sham comparator | Subjects will undergo training without AI for the study period Receives: Diagnostic Test: Conventional colonoscopy training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Secondary outcomes (4)
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.
Measured: 3 months
Adenoma Detection Rate (ADR)
ADR is defined as the proportion of individuals who have at least one histologically confirmed conventional adenoma.
Measured: 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).
Measured: 3 months
Adverse events rate
Adverse events defined by the ASGE lexicon
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2026
- Study start1 Feb 2026 (estimated)
- Primary completion1 Mar 2027 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colonoscopy TrainingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Thessaly
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Apostolis Papaefthymiou, University of Thessaly
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07420309
- Sponsor's protocol ID
- 31637-23/07/2025
- Acronym
- c-TRAINER
- Status last verified
- Feb 2026
- First submitted
- 13 Jan 2026
- Last updated
- 19 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Colonoscopy Training With or Without Artificial Intelligence Among Endoscopy Residents: a Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT07420309
- Acronym / sponsor ID
- c-TRAINER / 31637-23/07/2025
- Conditions
- Colonoscopy Training
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University of ThessalyUniversity, hospital or other
- Study start
- 1 Feb 2026 (estimated)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 19 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CADe assisted colonoscopy | Experimental | Diagnostic Test: Artificial Intelligence in colonoscopyTrainees will be trained with the use of CADe |
| Conventional colonoscopy | Sham comparator | Diagnostic Test: Conventional colonoscopy trainingSubjects will undergo training without AI for the study period |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (7 listed)
- Trial participants: Endoscopy trainees after their basic training, during the last year of training or with systematic exposure to CADe.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Artificial Intelligence in colonoscopyTraining in colonoscopy with or without CADe | Diagnostic test | CADe assisted colonoscopy |
| Conventional colonoscopy trainingThe trainees will be trained with the conventional colonoscopy for the study period | Diagnostic test | Conventional colonoscopy |
Primary outcome
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.
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Artificial Intelligence in colonoscopy and Conventional colonoscopy training in people with Colonoscopy Training, run by University of Thessaly at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Apostolis Papaefthymiou (00306973853042, appapaefthymiou@uth.gr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adenoma Miss Rate (AMR) at the end of the first year of training for each group and after the crossover. (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2026; AzTrials last refreshed its copy on 26 Oct 2026.