Polyp REcognition Assisted by a Device Interactive Characterization Tool - The PREDICT Study (PREDICT)

Diminutive colorectal polyps (≤ 5 mm) represent most of the polyps detected during colonoscopy, especially in the rectum-sigmoid tract. The characterization of these polyps by virtual chromoendoscopy is recognized as a key element for innovative imaging techniques. As a matter of facts diminutive colorectal polyps are very frequent and, if located in the rectosigmoid colon, they present a very low malignant risk (0.3% of evolution towards advanced adenoma and up to 0.08% of evolution towards invasive carcinoma). The real-time characterization would allow to identify the lowest risk polyps (hyperplastic subtype), to leave them in situ or, if resected, not to send them for histological examination, allowing a huge saving in healthcare associated costs.

Recently, the American Society for Gastrointestinal Endoscopy (ASGE) Technology Committee established the Preservation and Incorporation of Valuable endoscopic Innovations (PIVI) document, specific for real-time histological assessment for tiny colorectal polyps, to establish reference quality thresholds. Two performance standards have been developed to guide the use of advanced imaging:

1. for diminutive polyps to be resected and discarded without pathologic assessment, endoscopic technology (when used with high confidence) used to determine histology of polyps ≤ 5mm in size, when combined with the histopathology assessment of polyps > 5 mm in size, should provide a ≥ 90% agreement in assignment of post-polypectomy surveillance intervals when compared to decisions based on pathology assessment of all identified polyps;
2. in order for a technology to be used to guide the decision to leave suspected rectosigmoid hyperplastic polyps ≤ 5 mm in size in place (without resection), the technology should provide ≥ 90% negative predictive value (when used with high confidence) for adenomatous histology.

Computer-Aided-Diagnosis (CAD) is an artificial intelligence-based tool that would allow rapid and objective characterization of these lesions. The GI Genius CADx was developed to help endoscopists in their clinical practices for polyps characterization.

Study Overview

• Status: Completed
• Conditions: Artificial Intelligence
• Intervention / Treatment: Device: GI Genius CADe system

• Study Type: Observational
• Enrollment (Actual): 200

Contacts and Locations

Study Locations

• Italy
  • Milano
    • Rozzano, Milano, Italy, 20089
      • Endoscopy Unit, Humanitas Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients aged 40-80 undergoing colonoscopy

Description

Inclusion Criteria:

• Patients aged 40-80 undergoing screening colonoscopy for CRC
• Ability to provide written, informed consent (approved by EC) and understand the responsibilities of trial participation.

Exclusion Criteria:

• subjects positive to Fecal Immunochemical Test or Fecal Occult Blood Test;
• subjects undergoing CRC surveillance colonoscopy
• subject at high risk for CRC
• subjects with a personal history of CRC, IBD or hereditary polyposic or non-polyposic 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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Interficial Intelligence; Each patient will undergo standard white-light colonoscopy with the support of the latest version of the CE marked GI Genius CADe available.	Device: GI Genius CADe system; Each patient will undergo standard white-light colonoscopy with the support of the latest version of the CE marked GI Genius CADe available.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Negative Predictive Value of histology prediction on diminutive (≤5 mm) rectosigmoid polyps	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Agreement in assignment of post-polypectomy surveillance intervals	Agreement in assignment of post-polypectomy surveillance intervals according to established guidelines between: the assignment identified according to the combinedGI Genius CADx histology prediction for diminutive (≤5 mm) polyps andhistology for larger polyps (> 5 mm), and; the assignment identified according to histology only.	1 day

Other Outcome Measures

Outcome Measure	Time Frame
Sensitivity, Specificity, Accuracy, PPV and NPV of GI Genius CADx histology prediction and endoscopist assessment on all the identified lesions	1 day

Collaborators and Investigators

• Sponsor: Cosmo Artificial Intelligence-AI Ltd

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 8, 2020
• Primary Completion (ACTUAL): December 22, 2020
• Study Completion (ACTUAL): December 22, 2020

Study Registration Dates

• First Submitted: October 13, 2020
• First Submitted That Met QC Criteria: October 13, 2020
• First Posted (ACTUAL): October 19, 2020

Study Record Updates

• Last Update Posted (ACTUAL): May 12, 2021
• Last Update Submitted That Met QC Criteria: May 10, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: CB-17-08/05

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No