Colonic Polyp Size Measurement With Artificial Intelligence

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Colon Polyp Artificial Intelligence Colonic Polyps Intestinal Polyps Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Polyps

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ospedale dei Castelli

Ariccia, Rome, 00040, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Colonic Polyp Measurement Assessment Via Artificial Intelligence

Device

In this study, we collect colonoscopy video clips of polyps and, among the related clinical information, their estimated size using the gold standard technique, and we use them offline to evaluate the measurement performances of the novel virtual polyp sizing tool

Primary outcomes

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.
- 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

Secondary outcomes

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.
- 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

Sponsors and collaborators

Lead sponsor

University of Roma La Sapienza

Other

Registry information

Official study title

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

Important dates

Study start: 2023
Primary completion: 2024
Study completion: 2024
First posted: Oct 10, 2023
Registry last updated: Oct 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed