Colonic Polyp Size Measurement With Artificial Intelligence

NCT06073405 | Completed FDA Device

• 1 other identifier: METER
• Study Type: observational
• Target: 225
• Locations: 1 country
• Sites: 1

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).

Conditions

Colon Polyp; Artificial Intelligence

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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.

Interventions

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients aged 18 years or older undergoing colonoscopy

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Roma La Sapienza: lead

Study Sites (1)

Ospedale dei Castelli

Ariccia, Rome, 00040, Italy

Location

MeSH Terms

Conditions

Colonic Polyps

Condition Hierarchy (Ancestors)

Intestinal Polyps; Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 3, 2023
• First Posted: October 10, 2023
• Study Start: January 1, 2023
• Primary Completion: April 20, 2024
• Study Completion: September 30, 2024
• Last Updated: October 29, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share

Locations

IT (1)