NCT07125300

Brief Summary

The goal of this clinical trial is to determine whether using artificial intelligence (AI) can improve the detection and characterization of abnormal growths (polyps) during colonoscopy in adults aged 50 to 74 years who are undergoing colorectal cancer screening after a positive stool test. The main questions it aims to answer are:

  • Does AI assistance increase the detection of adenomas or advanced colorectal neoplasia?
  • Does AI provide more accurate optical diagnosis of polyps compared to standard assessment by endoscopists? Researchers will compare colonoscopies performed with AI assistance (using the CAD EYE™ system) to standard colonoscopies without AI to see if AI improves detection rates or diagnostic accuracy. Participants will:
  • Undergo a screening colonoscopy after a positive fecal immunochemical test (FIT)
  • Be randomly assigned to either an AI-assisted or standard colonoscopy group
  • Have any detected polyps removed and analyzed
  • Receive either AI-based or physician-based optical diagnosis of polyps during the procedure This study helps evaluate whether AI can make colonoscopies more effective and reduce unnecessary polyp removals.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
368

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2023

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

October 1, 2023

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2025

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 25, 2025

Completed
21 days until next milestone

First Posted

Study publicly available on registry

August 15, 2025

Completed
Last Updated

August 15, 2025

Status Verified

August 1, 2025

Enrollment Period

1.4 years

First QC Date

July 25, 2025

Last Update Submit

August 12, 2025

Conditions

Colorectal NeoplasmsColorectal CancerAdenoma Colon Polyp

Keywords

Colorectal cancer screeningColonoscopyArtificial IntelligenceCADeCADx

Outcome Measures

Primary Outcomes (1)

  • To compare the adenoma detection rate (ADR) and advanced colorectal neoplasia detection rate between conventional colonoscopy and AI-assisted colonoscopy.

    During the screening colonoscopy visit (single time point assessment on the day of the procedure).

Secondary Outcomes (1)

  • To compare mean number of lesions between conventional colonoscopy and AI-assisted colonoscopy.

    During the screening colonoscopy visit (single time point assessment on the day of the procedure).

Study Arms (2)

Conventional colonoscopy without AI assistance

NO INTERVENTION

AI-assisted colonoscopy

EXPERIMENTAL
Diagnostic Test: Artificial Intelligence-Assisted Colonoscopy

Interventions

Artificial Intelligence-Assisted ColonoscopyDIAGNOSTIC_TEST

The intervention involves the use of an artificial intelligence tool during screening colonoscopy. This system includes two integrated functions: * CADe (Computer-Aided Detection): Highlights suspected lesions in real time on the endoscopic video to assist in identifying polyps. * CADx (Computer-Aided Diagnosis): Provides real-time optical histology predictions to help distinguish between hyperplastic and adenomatous polyps. The AI system operates autonomously during the procedure and displays visual cues on the monitor to support the endoscopist in detecting and characterizing colorectal lesions.

AI-assisted colonoscopy

Eligibility Criteria

Age50 Years - 74 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults aged 50 to 74 years
  • Positive fecal immunochemical test (FIT) result (≥100 ng/mL)
  • Scheduled for screening colonoscopy within a population-based colorectal cancer screening program
  • Able and willing to provide written informed consent

You may not qualify if:

  • Incomplete colonoscopy (e.g., failure to reach the cecum)
  • Inadequate bowel preparation
  • History of colorectal surgery
  • Inability to provide informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Care Complex of Palencia

Palencia, Spain

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Clinical Trials Coordinator

Study Record Dates

First Submitted

July 25, 2025

First Posted

August 15, 2025

Study Start

October 1, 2023

Primary Completion

February 28, 2025

Study Completion

February 28, 2025

Last Updated

August 15, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)