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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06073405
Other study ID # METER
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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.
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