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Characterization of Colorectal Neoplasia (CHANGE)

Primary Purpose

Colonic Polyp

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
GI Genius CADx device
Sponsored by
Nuovo Regina Margherita Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Colonic Polyp

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients aged 40 years or older undergoing screening colonoscopy for CRC
  • Ability to provide written, informed consent (approved by EC) and understand the responsibilities of trial participation

Exclusion Criteria:

  • subjects at high risk for colorectal cancer
  • subjects with a personal history of CRC, IBD or hereditary polyposis or non-polyposis syndromes
  • patients with previous resection of the sigmoid rectum
  • patients on anticoagulant therapy, which precludes resection / removal operations due to histopathological findings
  • patients who perform an emergency colonoscopy

Sites / Locations

  • Nuovo Regina Margherita

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

GI Genius CADx device

Arm Description

Outcomes

Primary Outcome Measures

Negative Predictive Value (NPV)
Negative Predictive Value (NPV) of GI Genius CADx optical diagnosis on diminutive (≤5 mm) rectosigmoid polyps

Secondary Outcome Measures

Full Information

First Posted
May 7, 2021
Last Updated
August 5, 2021
Sponsor
Nuovo Regina Margherita Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04884581
Brief Title
Characterization of Colorectal Neoplasia
Acronym
CHANGE
Official Title
The CHANGE Study: Characterization Helping the Assessment of Colorectal Neoplasia in Gastrointestinal Endoscopy
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
May 12, 2021 (Actual)
Primary Completion Date
July 1, 2021 (Actual)
Study Completion Date
August 5, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nuovo Regina Margherita Hospital

4. Oversight

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

5. Study Description

Brief Summary
This is a post-marketing, single-arm, prospective study investigating the use of GI Genius CADx device in the real-time characterization of colorectal polyps (i.e. prediction of their histology during the colonoscopy). Patients enrolled will undergo a standard white-light colonoscopy with the support of the latest version of the CE-marked GI Genius CADx device. Colonoscopy will be performed according to the standard practice.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
165 (Actual)

8. Arms, Groups, and Interventions

Arm Title
GI Genius CADx device
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
GI Genius CADx device
Intervention Description
GI Genius System is an Intelligent Endoscopy Module designed to be an adjunct to video colonoscopy with the purpose of supporting the operating physician with artificial intelligence during colonoscopy. GI Genius CADx is the AI software that provides a histology prediction of framed polyps during real-time colonoscopy, with each polyp being classified as adenoma or non-adenoma.
Primary Outcome Measure Information:
Title
Negative Predictive Value (NPV)
Description
Negative Predictive Value (NPV) of GI Genius CADx optical diagnosis on diminutive (≤5 mm) rectosigmoid polyps
Time Frame
4 months
Other Pre-specified Outcome Measures:
Title
Post-polypectomy surveillance interval
Description
Agreement in assignment of post-polypectomy surveillance intervals of the enrolled patients according to established guidelines between the combined use of GI Genius CADx as optical diagnosis for diminutive (≤5 mm) polyps and conventional histology as diagnostic tool for polyps > 5 mm, and histology as diagnostic tool for all the resected polyps (regardless of size or location)
Time Frame
4 months
Title
Performance metrics of GI Genius CADx
Description
Sensitivity, Specificity, Accuracy, PPV and NPV of GI Genius CADx optical diagnosis
Time Frame
4 months
Title
Performance metrics of the endoscopist with the aid of GI Genius CADx
Description
Sensitivity, Specificity, Accuracy, PPV and NPV of the optical diagnosis of endoscopists assessing lesions in white-light with the help of GI Genius CADx.
Time Frame
4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients aged 40 years or older undergoing screening colonoscopy for CRC Ability to provide written, informed consent (approved by EC) and understand the responsibilities of trial participation Exclusion Criteria: subjects at high risk for colorectal cancer subjects with a personal history of CRC, IBD or hereditary polyposis or non-polyposis syndromes patients with previous resection of the sigmoid rectum patients on anticoagulant therapy, which precludes resection / removal operations due to histopathological findings patients who perform an emergency colonoscopy
Facility Information:
Facility Name
Nuovo Regina Margherita
City
Roma
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35835342
Citation
Hassan C, Balsamo G, Lorenzetti R, Zullo A, Antonelli G. Artificial Intelligence Allows Leaving-In-Situ Colorectal Polyps. Clin Gastroenterol Hepatol. 2022 Nov;20(11):2505-2513.e4. doi: 10.1016/j.cgh.2022.04.045. Epub 2022 Jul 11.
Results Reference
derived

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Characterization of Colorectal Neoplasia

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