NCT05545189

Brief Summary

We have been developing artificial intelligence based polyp histology prediction (AIPHP) method to classify Narrow Band Imaging(NBI) colonoscopy images to predict the hyperplastic or neoplastic histology of polyps. We plan to study colonoscopy polyp samples taken by polypectomy from 1200 patients.The documented NBI still images will be analyzed by the AIPHP method and by the NICE classification parallel.Our aim is to analyze the accuracy of AIPHP and NBI classification based histology predictions and also compare the results of the two methods.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2022

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 14, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 19, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

October 31, 2022

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2024

Completed
Last Updated

September 22, 2022

Status Verified

September 1, 2022

Enrollment Period

1.2 years

First QC Date

September 14, 2022

Last Update Submit

September 20, 2022

Conditions

Keywords

colorectal polyp,histology,artificial intelligence

Outcome Measures

Primary Outcomes (1)

  • Polyp histology accuracy by AI method

    polyp histology prediction by AI

    two weeks

Study Arms (6)

colonoscopy group1

Polypectomy, histological examination, NICE classification and AIPHP analyzis will be performed 200 patients.

Diagnostic Test: colonoscopy,polypectomy

colonoscopy group 2

Polypectomy, histological examination, NICE classification and AIPHP analyzis will be performed 200 patients

Diagnostic Test: colonoscopy,polypectomy

colonoscopy group 3

Polypectomy, histological examination, NICE classification and AIPHP analyzis will be performed 200 patients

Diagnostic Test: colonoscopy,polypectomy

colonoscopy group 4

Polypectomy, histological examination, NICE classification and AIPHP analyzis will be performed 200 patients

Diagnostic Test: colonoscopy,polypectomy

colonoscopy group 5

Polypectomy, histological examination, NICE classification and AIPHP analyzis will be performed 200 patients

Diagnostic Test: colonoscopy,polypectomy

colonoscopy group 6

Polypectomy, histological examination, NICE classification and AIPHP analyzis will be performed 200 patients

Diagnostic Test: colonoscopy,polypectomy

Interventions

polyp removal during colonoscopy

colonoscopy group 2colonoscopy group 3colonoscopy group 4colonoscopy group 5colonoscopy group 6colonoscopy group1

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients with colorectal polyps detected by colonoscopy

You may qualify if:

  • colorectal polyps removed by polypectomy

You may not qualify if:

  • colorectal polyps with IBD

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Colonoscopy

Intervention Hierarchy (Ancestors)

Endoscopy, GastrointestinalEndoscopy, Digestive SystemDiagnostic Techniques, Digestive SystemDiagnostic Techniques and ProceduresDiagnosisEndoscopyDiagnostic Techniques, SurgicalDigestive System Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical Procedures

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
3 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 14, 2022

First Posted

September 19, 2022

Study Start

October 31, 2022

Primary Completion

December 31, 2023

Study Completion

March 31, 2024

Last Updated

September 22, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share