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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

1800 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-21

Study Completion Date

2027-09-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Using AI-assisted Optical Polyp Diagnosis for Diminutive Colorectal Polyps

NCT06059378

Artificial Intelligence

RECRUITING NA

Assessing the Additional Neoplasia Yield of Computer-aided Colonoscopy in a Screening Setting

NCT04441580

Colonic Neoplasms Colonic Adenocarcinoma Polyps of Colon +2 more

COMPLETED NA

Combining Artificial Intelligence With Balloon Mucosal Exposure Device for Polyp Detection in Screening Individuals

NCT05829447

Polyp of Colon

COMPLETED NA

Real-time AI-assisted Endocyroscopy for the Diagnosis of Colorectal Lesions

NCT06791395

Colorectal Polyp Colorectal Neoplasms

RECRUITING

Comparing the Number of False Activations Between Two Artificial Intelligence CADe Systems: the NOISE Study

NCT04399590

Artificial Intelligence

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Colonic Neoplasms

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type ACTIVE_COMPARATOR

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

Intervention Type DEVICE

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

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.

Group Type ACTIVE_COMPARATOR

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

Intervention Type DEVICE

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

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.

Group Type EXPERIMENTAL

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

Intervention Type DEVICE

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type 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.

Intervention Type 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.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

* patients with personal history of CRC, or IBD
* patients affected with Lynch syndrome or Familiar Adenomatous Polyposis.
* patients with inadequate bowel preparation (defined as Boston Bowel Preparation Scale \<2 in any colonic segment).
* patients with previous colonic resection.
* patients on antithrombotic therapy, precluding polyp resection.
* patients who were not able or refused to give informed written consent.

Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes