NCT06041945View on ClinicalTrials.gov

Artificial Intelligence to Implement Cost-saving Strategies for Colonoscopy Screening Based on in Vivo Prediction of Polyp Histology

NARecruitingINTERVENTIONAL
Enrollment

1,800

Participants

Timeline

Start Date

September 21, 2023

Primary Completion Date

September 1, 2027

Study Completion Date

September 1, 2027

Conditions
Colonic Neoplasms
Interventions
DEVICE

Standard, high-definition colonoscopy with the use of CADe assistance

All detected polyps regardless of size and optical diagnosis will be resected and sent to pathology.

DEVICE

Standard, high-definition colonoscopy with the use of CADe/CADx assistance, no leave-in-situ

All detected polyps regardless of size and optical diagnosis will be resected and sent to pathology.

DEVICE

Standard, high-definition colonoscopy with the use of CADe/CADx assistance, leave-in-situ

Polyps will be left in situ if diminutive (≤5 mm) in size, located in the rectum or sigma and optically diagnosed by the endoscopist using the system to be hyperplastic with high confidence, otherwise resected and sent to pathology.

Trial Locations (2)

20089

RECRUITING

Istituto Clinico Humanitas, Rozzano

RECRUITING

Istituto Clinico Humanitas, Rozzano

All Listed Sponsors
lead

Istituto Clinico Humanitas

OTHER