Colonic Polyp Size Measurement With Artificial Intelligence

Artificial Intelligence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06073405
• Other study ID #: METER
• Status: Recruiting
• Start date: January 1, 2023
• Est. completion date: March 30, 2024

Study information

• Verified date: October 2023
• Source: University of Roma La Sapienza
• Contact: Giulio Antonelli
• Phone: +393391973276
• Email: giulio.antonelli[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 190
• Est. completion date: March 30, 2024
• Est. primary completion date: November 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Artificial Intelligence
• Colon Polyp
• Polyps

Intervention

Device:
• Colonic Polyp Measurement Assessment Via Artificial Intelligence
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

Locations

Country	Name	City	State
Italy	Ospedale dei Castelli	Ariccia	Rome

Sponsors (1)

Lead Sponsor	Collaborator
University of Roma La Sapienza

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Accuracy for categorical distribution of polyp size	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	Accuracy for continous determination of polyp size	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.