NCT07420309

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. 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
14mo left

Started Feb 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress19%
Feb 2026Jul 2027

First Submitted

Initial submission to the registry

January 13, 2026

Completed
19 days until next milestone

Study Start

First participant enrolled

February 1, 2026

Completed
18 days until next milestone

First Posted

Study publicly available on registry

February 19, 2026

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2027

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2027

Last Updated

February 19, 2026

Status Verified

February 1, 2026

Enrollment Period

1.1 years

First QC Date

January 13, 2026

Last Update Submit

February 11, 2026

Conditions

Colonoscopy Training

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Polyp Miss Rate (PMR)

    3 months

  • Adenoma Detection Rate (ADR)

    3 months

  • Polyp Detection Rate (PDR)

    3 months

  • Adverse events rate

    3 months

Study Arms (2)

CADe assisted colonoscopy

EXPERIMENTAL

Trainees will be trained with the use of CADe

Diagnostic Test: Artificial Intelligence in colonoscopy

Conventional colonoscopy

SHAM COMPARATOR

Subjects will undergo training without AI for the study period

Diagnostic Test: Conventional colonoscopy training

Interventions

Artificial Intelligence in colonoscopyDIAGNOSTIC_TEST

Training in colonoscopy with or without CADe

CADe assisted colonoscopy
Conventional colonoscopy trainingDIAGNOSTIC_TEST

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

Conventional colonoscopy

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

General University Hospital of Larissa

Larissa, Greece

RECRUITING

MeSH Terms

Interventions

Artificial IntelligenceColonoscopy

Intervention Hierarchy (Ancestors)

AlgorithmsMathematical ConceptsEndoscopy, GastrointestinalEndoscopy, Digestive SystemDiagnostic Techniques, Digestive SystemDiagnostic Techniques and ProceduresDiagnosisEndoscopyDiagnostic Techniques, SurgicalDigestive System Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical Procedures

Central Study Contacts

Apostolis Papaefthymiou

CONTACT

00306973853042appapaefthymiou@uth.gr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

January 13, 2026

First Posted

February 19, 2026

Study Start

February 1, 2026

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

July 1, 2027

Last Updated

February 19, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

GR(1)