MedTrace Logo

Optical Diagnosis of Neoplasia Using Artificial Intelligence

NCT07158203 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2025-09-05

No results posted yet for this study

Summary

Computer-aided diagnosis (CADx) for colonoscopy aims to enhance optical diagnosis but often underperforms when used alongside humans due to under-reliance on AI. Psychological interventions like cognitive forcing, such as delaying CADx suggestions, may improve human-AI interaction by fostering critical assessment. However, their impact on patient-important outcomes remains unexplored.

The investigators will conduct an ex-vivo randomized study with 70 endoscopists assessing 100 polyp videos (≤5 mm) using a CADx tool (GI Genius, Medtronic). Participants will be randomized to either:

* Intervention group: CADx suggestions will be shown in the last 3 seconds of the 15 second polyp video.
* Control group: CADx suggestions will be shown in real-time throughout the playback of the 15 second polyp video.

The primary endpoint is sensitivity for high-confidence neoplasia detection, with secondary endpoints assessing endoscopists' reliance on AI.

CADx systems on the market function in various ways, such as real-time, delayed, or on-demand diagnosis. Our study aims to inform users and manufacturers whether cognitive forcing through delayed CADx suggestions enhances human-AI interaction, leading to improved clinical outcomes.

Conditions

  • Polyps Colorectal
  • Colonoscopy
  • Optical Biopsy
  • Colorectal Cancer Control and Prevention
  • Colorectal Cancer Screening
  • Behavior Change
  • Psychological Factors
  • Psychological Intervention

Interventions

DEVICE

CADx simultaneously

The investigators showed the CADx suggestion during the 15-second playback of the video

BEHAVIORAL

CADx delayed

During the 15-seconds polyp video the CADx suggestion appear only in the last 3 seconds of the video

Sponsors & Collaborators

  • Fundacin Biomedica Galicia Sur

    lead OTHER

Principal Investigators

  • Yuichi Mori, MD, PhD · Clinical Effectiveness Research group

  • Pedro Davila Piñón, Masters degree biotechnology · Research Group in Gastrointestinal Oncology Ourense / Galicia-Sur Public Galician Foundation

  • Joaquin Cubiella, MD, PhD · University Hospital of Ourense

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-09-30
Primary Completion
2025-11-30
Completion
2025-12-31
FDA Device
Yes

Countries

  • Norway
  • Spain

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07158203 on ClinicalTrials.gov