Saving by Artificial Intelligence for Virtual Endoscopy Biopsy Artificial Intelligence to Implement Cost-saving Strategies for Colonoscopy Screening Based on in Vivo Prediction of Polyp Histology

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

This three parallel-arms, randomized, multicenter trial is aimed at investigating the value of AI-assisted optical biopsy for differentiating between neoplastic and non-neoplastic polyps which will lead to the implementation of cost-saving strategies in screening programs. A cost-effectiveness analyses with the use of modern trial emulation analyses of large observational and clinical trial datasets and real-cost data will be conducted. To improve personalized treatment with a novel colonoscopy CADx risk-prediction tool, the investigators will even develop a novel deep learning algorithm for the optical biopsy of the alternative pathway of colorectal cancer carcinogenesis, namely the serrated pathway and develop cost-effectiveness models of AI-assisted optical biopsy in colorectal cancer screening that provides reliable information to identify cancer risk regardless of physicians' skill.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 40
Healthy Volunteers: t
View:

• All \>40 years-old patients undergoing colonoscopy for selected indications

Locations
Other Locations
Italy
Istituto Clinico Humanitas
RECRUITING
Rozzano
Istituto Clinico Humanitas
RECRUITING
Rozzano
Contact Information
Primary
Cesare Hassan
cesare.hassan@hunimed.eu
02-82247385
Time Frame
Start Date: 2023-09-21
Estimated Completion Date: 2027-09-01
Participants
Target number of participants: 1800
Treatments
Active_comparator: Standard Arm CADe
Standard, high-definition colonoscopy with the use of CADe assistance (GI-GENIUS, Medtronic; CAD-EYE, Fujifilm; WISE VISION ,NEC). All detected polyps regardless of size and optical diagnosis will be resected and sent to pathology.
Active_comparator: Standard Arm CADe/CADx
Standard, high-definition colonoscopy with the use of CADe/CADx assistance (GI-GENIUS, Medtronic; CAD-EYE, Fujifilm; WISE VISION ,NEC). All detected polyps regardless of size and optical diagnosis will be resected and sent to pathology.
Experimental: Leave-In-Situ Arm
Standard, high-definition colonoscopy with the use of CADe/CADx assistance (GI-GENIUS, Medtronic; CAD-EYE, Fujifilm; WISE VISION, NEC).~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.
Related Therapeutic Areas
Sponsors
Leads: Istituto Clinico Humanitas

This content was sourced from clinicaltrials.gov