NCT04425941

Brief Summary

Background We are developing artificial intelligence based polyp histology prediction (AIPHP) method to automatically classify Narrow Band Imaging (NBI) magnifying colonoscopy images to predict the non-neoplastic or neoplastic histology of polyps. Aim Our aim was to analyse the accuracy of AIPHP and NICE classification based histology predictions and also to compare the results of the two methods. Methods We examined colorectal polyps obtained from colonoscopy patients who had polypectomy or endoscopic mucosectomy. Polyps detected by white light colonoscopy were observed then by using NBI at the optical maximum magnificent (60x). The obtained and stored NBI magnifying images were analysed by NICE classification and by AIPHP method parallelly. Pathology examinations were performed blinded to the NICE and AIPHP diagnosis, as well. Our AIPHP software is based on a machine learning method. This program measures five geometrical and colour features on the endoscopic image.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
373

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2014

Longer than P75 for all trials

Status
completed

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

Study Start

First participant enrolled

January 5, 2014

Completed
6.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2020

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

June 5, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 11, 2020

Completed
Last Updated

June 11, 2020

Status Verified

June 1, 2020

Enrollment Period

6.4 years

First QC Date

June 5, 2020

Last Update Submit

June 9, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Software accuracy of polyp histology prediction

    Artificial intelligence software diagnosis in comparison with the polyp histology

    2014-2020

Interventions

artificial intelligence prediction of colorectal polyp histology

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients with symptoms of colorectal polypoid laesions, colorectal cancer screening patients

You may qualify if:

  • endoscopic diagnosis of colorectal polyp

You may not qualify if:

  • colonoscopy result without polyps or IBD diagnosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 5, 2020

First Posted

June 11, 2020

Study Start

January 5, 2014

Primary Completion

May 31, 2020

Study Completion

May 31, 2020

Last Updated

June 11, 2020

Record last verified: 2020-06