A Prospective Study to Evaluate the Diagnostic Accuracy of Computer-aided Diagnosis (CADx) System in Real-time Characterization of Colorectal Neoplasia

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorChinese University of Hong Kong

About this trial

The investigators hypothesize that a newly developed CADx system will have a higher diagnostic accuracy in predicting histopathology of colorectal neoplasia than both expert and junior endoscopists.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

They have received colonoscopy for screening, surveillance or symptom investigation;

They have endoscopic images and videos captured and stored during colonoscopy which are available to be retrieved;

They have histologically proven colorectal neoplasia.

Written consent obtained

Disqualifiers

Incomplete visualization of the colorectal neoplasia due to technical reasons (e.g. out-of-focus, motion-blurred or insufficient illumination);

Artifacts due to mucus, air bubbles, stool, or blood.

Active gastrointestinal bleeding;

Fulminant colitis;

Trial population

Patient with colorectal neoplasia

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • CADx

    Device

    A novel CADx system for real-time histopathological prediction of colorectal neoplasia, by using non-magnified conventional white-light and image enhanced endoscopy.

Treatment groups

510 Participants
are divided into 2 treatment groups
Group A: CADx1 intervention
Group B: Endoscopist0 interventions

Trial outcomes

Primary outcomes

1

Diagnostic accuracy

area under receiver operating characteristic curves, AUROC in prediction of final histopathology

Time frame
During the colonoscopy

Secondary outcomes

1

Sensitivity

Sensitivity

Time frame
During the colonoscopy
2

Specificity

Specificity

Time frame
During the colonoscopy
3

Positive predictive value

Positive predictive value

Time frame
During the colonoscopy
4

Negative predictive value

Negative predictive value

Time frame
During the colonoscopy

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Chinese University of Hong Kong

Lead sponsor

Nanfang Hospital, Southern Medical University

Collaborator

University College, London

Collaborator

This trial is not recruiting at the moment. You can still explore other options: