Colonic Polyp Size Measurement With Artificial Intelligence

• Sponsor: University of Roma La Sapienza (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT06073405
• Collaborator: (none)
• Enrollment: 190
• Location: 1
• Anticipated Duration (Months): 14.9
• Patients Per Site Per Month: 12.7

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Colon Polyp; Artificial Intelligence	Device: Colonic Polyp Measurement Assessment Via Artificial Intelligence

Study Design

• Study Type: Observational
• Anticipated Enrollment: 190 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: MEasuring the Accuracy of an Artificial Intelligence Tool That Establishes Polyp Size in Real-time
• Actual Study Start Date: Jan 1, 2023
• Anticipated Primary Completion Date: Nov 30, 2023
• Anticipated Study Completion Date: Mar 30, 2024

Outcome Measures

Primary Outcome Measures

1. 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

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.]

   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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ospedale dei Castelli	Ariccia	Rome	Italy	00040

Sponsors and Collaborators

• University of Roma La Sapienza

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Giulio Antonelli, Principal Investigator, University of Roma La Sapienza
• ClinicalTrials.gov Identifier: NCT06073405
• Other Study ID Numbers: METER
• First Posted: Oct 10, 2023
• Last Update Posted: Oct 12, 2023
• Last Verified: Oct 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Polyps

Study Results

No Results Posted as of Oct 12, 2023