Colonic Polyp Size Measurement With Artificial Intelligence

Completed

• Conditions: Colon Polyp; Artificial Intelligence

• Registration Number: NCT06073405
• Lead Sponsor: University of Roma La Sapienza

Brief 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2023-01-01
• Study First Submitted: 2023-10-03
• Study First Submitted QC: 2023-10-03
• Study First Posted: 2023-10-10
• Primary Completion: 2024-04-20
• Study Completion: 2024-09-30
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-28
• Last Update Posted: 2024-10-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 225

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Accuracy for categorical distribution of polyp 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.	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

Secondary Outcome Measures

Name	Time	Method
Accuracy for continous determination of polyp 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.	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

Trial Locations

Locations (1)

Ospedale dei Castelli; 🇮🇹 Ariccia, Rome, Italy