Colonic Polyp Size Measurement With Artificial Intelligence

October 28, 2024 updated by: Giulio Antonelli, University of Roma La Sapienza

MEasuring the Accuracy of an Artificial Intelligence Tool That Establishes Polyp Size in Real-time

Primary objective of the study is to evaluate if the novel virtual polyp sizing tool accuracy in determining the size class of polyps among diminutive (0-5 mm), small (6-9 mm) and large (10 mm and above).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

225

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Rome
      • Ariccia, Rome, Italy, 00040
        • Ospedale dei Castelli

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients aged 18 years or older undergoing colonoscopy

Description

Inclusion criteria:

  • Patients aged 18 years or older undergoing colonoscopy
  • Ability to provide written, informed consent (approved by EC) and understand the responsibilities of trial participation.

Exclusion criteria:

  • Patients with known contra-indications to colonoscopy
  • Patients who perform an emergency colonoscopy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Accuracy for categorical distribution of polyp size
Time Frame: at study completion (this outcome is not an outcome measured from Time A to Time B but an outcome measured in one time point for all the colonoscopies performed in the study.
1. Accuracy of the novel virtual polyp sizing tool in the determination of polyp size class among diminutive (0-5 mm), small (6-9 mm) and large (10 mm and above) as compared to the size estimated in-vivo by performing endoscopists with the help of a side-by-side forceps of known size
at study completion (this outcome is not an outcome measured from Time A to Time B but an outcome measured in one time point for all the colonoscopies performed in the study.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Accuracy for continous determination of polyp size
Time Frame: at study completion (this outcome is not an outcome measured from Time A to Time B but an outcome measured in one time point for all the colonoscopies performed in the study.
1. Polyp size in mm as determined by the novel virtual polyp sizing tool as compared to the size estimated in-vivo by performing endoscopists with the help of a side-by-side forceps of known size
at study completion (this outcome is not an outcome measured from Time A to Time B but an outcome measured in one time point for all the colonoscopies performed in the study.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Roma La Sapienza

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2023

Primary Completion (Actual)

April 20, 2024

Study Completion (Actual)

September 30, 2024

Study Registration Dates

First Submitted

October 3, 2023

First Submitted That Met QC Criteria

October 3, 2023

First Posted (Actual)

October 10, 2023

Study Record Updates

Last Update Posted (Actual)

October 29, 2024

Last Update Submitted That Met QC Criteria

October 28, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • METER

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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