search
Back to results

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

Primary Purpose

Colonic Neoplasms

Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Standard, high-definition colonoscopy with the use of CADe assistance
Standard, high-definition colonoscopy with the use of CADe/CADx assistance, no leave-in-situ
Standard, high-definition colonoscopy with the use of CADe/CADx assistance, leave-in-situ
Sponsored by
Istituto Clinico Humanitas
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Colonic Neoplasms

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Istituto Clinico HumanitasRecruiting
  • Istituto Clinico HumanitasRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Experimental

Arm Label

Standard Arm CADe

Standard Arm CADe/CADx

Leave-In-Situ Arm

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Non-inferiority in Adenoma Detection Rate
Non-inferiority in the Adenoma Detection Rate, defined as the proportion of participants with at least one adenoma (per-patient analysis) in the three arms, when adopting a cost-saving leave-in-situ strategy for non-neoplastic rectosigmoid diminutive polyps.

Secondary Outcome Measures

Negative Predictive Value for colorectal neoplasia
Negative Predictive Value for colorectal neoplasia when adopting a leave-in-situ strategy for rectosigmoid diminutive polyps based on the use of Artificial Intelligence.
Concordance between post-polypectomy surveillance and when adopting a leave-in-situ strategy
Concordance between post-polypectomy surveillance based on strategies based on optical diagnosis with Artificial Intelligence and those based on histology, and when adopting a leave-in-situ strategy for colorectal diminutive polyps based on the use of Artificial Intelligence
Change in the cost of polypectomy and histology in screening programs
Change in the cost of polypectomy and histology in screening programs, when implementing strategies based on Artificial Intelligence-based optical biopsy, without changes in benefit related with detection of colorectal neoplasia

Full Information

First Posted
September 4, 2023
Last Updated
October 3, 2023
Sponsor
Istituto Clinico Humanitas
search

1. Study Identification

Unique Protocol Identification Number
NCT06041945
Brief Title
Artificial Intelligence to Implement Cost-saving Strategies for Colonoscopy Screening Based on in Vivo Prediction of Polyp Histology
Acronym
SAVE
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 21, 2023 (Actual)
Primary Completion Date
September 1, 2027 (Anticipated)
Study Completion Date
September 1, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Istituto Clinico Humanitas

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colonic Neoplasms

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1800 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standard Arm CADe
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Standard Arm CADe/CADx
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Leave-In-Situ Arm
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Standard, high-definition colonoscopy with the use of CADe assistance
Intervention Description
All detected polyps regardless of size and optical diagnosis will be resected and sent to pathology.
Intervention Type
Device
Intervention Name(s)
Standard, high-definition colonoscopy with the use of CADe/CADx assistance, no leave-in-situ
Intervention Description
All detected polyps regardless of size and optical diagnosis will be resected and sent to pathology.
Intervention Type
Device
Intervention Name(s)
Standard, high-definition colonoscopy with the use of CADe/CADx assistance, leave-in-situ
Intervention Description
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.
Primary Outcome Measure Information:
Title
Non-inferiority in Adenoma Detection Rate
Description
Non-inferiority in the Adenoma Detection Rate, defined as the proportion of participants with at least one adenoma (per-patient analysis) in the three arms, when adopting a cost-saving leave-in-situ strategy for non-neoplastic rectosigmoid diminutive polyps.
Time Frame
4 years
Secondary Outcome Measure Information:
Title
Negative Predictive Value for colorectal neoplasia
Description
Negative Predictive Value for colorectal neoplasia when adopting a leave-in-situ strategy for rectosigmoid diminutive polyps based on the use of Artificial Intelligence.
Time Frame
4 years
Title
Concordance between post-polypectomy surveillance and when adopting a leave-in-situ strategy
Description
Concordance between post-polypectomy surveillance based on strategies based on optical diagnosis with Artificial Intelligence and those based on histology, and when adopting a leave-in-situ strategy for colorectal diminutive polyps based on the use of Artificial Intelligence
Time Frame
4 years
Title
Change in the cost of polypectomy and histology in screening programs
Description
Change in the cost of polypectomy and histology in screening programs, when implementing strategies based on Artificial Intelligence-based optical biopsy, without changes in benefit related with detection of colorectal neoplasia
Time Frame
4 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cesare Hassan
Phone
02-82247385
Email
cesare.hassan@hunimed.eu
Facility Information:
Facility Name
Istituto Clinico Humanitas
City
Rozzano
State/Province
Milano
ZIP/Postal Code
20089
Country
Italy
Individual Site Status
Recruiting
Facility Name
Istituto Clinico Humanitas
City
Rozzano
State/Province
Milano
ZIP/Postal Code
20089
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cesare Hassan, Prof/MD
Phone
0039-02-82247385
Email
cesare.hassan@hunimed.eu
First Name & Middle Initial & Last Name & Degree
Cesare Hassan

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs