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Colonic Polyp Size Measurement With Artificial Intelligence

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06073405
Enrollment
225
Registered
2023-10-10
Start date
2023-01-01
Completion date
2024-09-30
Last updated
2024-10-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Artificial Intelligence, Colon Polyp

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).

Interventions

DEVICEColonic 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

Sponsors

University of Roma La Sapienza
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Accuracy for categorical distribution of polyp sizeat 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

MeasureTime frameDescription
Accuracy for continous determination of polyp sizeat 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

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026