Identification of Hypospadias Parameters Using Digital Photography and Artificial Intelligence (ASHOKA)

October 4, 2022 updated by: Irfan Wahyudi, MD, PhD, Indonesia University

Digital Pattern Recognition for Identification of Various Hypospadias Parameters Based on Digital Photography Using Artificial Neural Network

The goal of this observational study is to develop and validate a digital pattern recognition system based on artificial neural network to determine various parameters in hypospadias. The main question it aims to answer is:

How accurate is the digital pattern recognition system based on artificial neural network to determine various parameters in hypospadias?

Participants in this study are hypospadias patients aged < 18 years old. The guardian (and the patient, if applicable) will be informed about the study and asked for consent. The digital picture of participants' penis will be taken from different angles according to the predetermined angle.

The clinical characteristics of the photographed penis are then inputted and used to train a customized artificial neural network (ANN). The machine is then used to predict various hypospadias parameters presenting at the patients' penis. The accuracy of the machine is then compared to the measurement done by pediatric urologists.

Study Overview

Status

Not yet recruiting

Conditions

Detailed Description

This is a development protocol for a digital pattern recognition program for identification of various hypospadias parameters using artificial neural network. The population for this study are children suspected of having hypospadias who are admitted or referred to hospitals in Indonesia.

The consent for the capture of the images needed in the study will be obtained from the parents of hypospadias patients as part of the standard of care to be used as a clinical reference. The photograph taken for this study were kept in an encrypted database. The inclusion criteria of this study are children aged <18 years old who are suspected of having hypospadias, with age-matched control. Those with history of hypospadias repair or those who refuse to participate in the study are excluded.

The clinical outcomes measured in this study are:

  1. Hypospadias status: hypospadias or non-hypospadias
  2. Meatal location: glanular, coronal, distal shaft, proximal shaft, penoscrotal
  3. Meatal shape: normal, abnormal
  4. Quality of the urethral plate: good, bad
  5. Glans diameter: in mm
  6. Glans shape: normal, abnormal The clinical outcomes were measured preoperatively and 1 month postoperatively

A hypospadias and normal penis image with matched age database was used to train the artificial neural network. Three image aspects of the penis (ventral, dorsal, and lateral aspect which include the glans, shaft, and scrotum) were taken from each subjects. The data was labeled with hypospadias parameters: hypospadias status, meatal location, meatal shape, quality of the urethral plate, glans diameter, and glans shape. The data were uploaded to train the artificial neural network.

The statistical analysis plan will be followed for all clinical outcomes analyses. Standard error, 95% confidence intervals, and P values will be reported whenever possible. Intra and inter rater analysis will be performed using the Fleiss Kappa statistical analysis. The data is deemed to be statistically significant if the p-value is less than 0.05. In addition, accuracy, precision, recall, and f1 score values will be computed to measure the performance of recognition model.

Study Type

Observational

Enrollment (Anticipated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

The diagnosis of having hypospadias (or not) is established via clinical examination by a pediatric urologist.

Description

Inclusion Criteria:

  • Children aged <18 years old
  • Suspected of having hypospadias (hypospadias group)
  • Diagnosed as not having hypospadias (control group)

Exclusion Criteria:

  • History of hypospadias repair
  • Refusal to participate in the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Hypospadias group
Patients with hypospadias diagnosis
Control group
Patients without hypospadias

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Accuracy of The Digital Pattern Recognition Model
Time Frame: 1 month

Accuracy of the digital pattern recognition model compared to clinical assessment by pediatric urologists in measuring:

  1. Hypospadias status: hypospadias or non-hypospadias
  2. Meatal location: glanular, coronal, distal shaft, proximal shaft, penoscrotal
  3. Meatal shape: normal, abnormal
  4. Quality of the urethral plate: good, bad
  5. Glans diameter: in mm
  6. Glans shape: normal, abnormal
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Indonesia University

Collaborators

University Ghent

Investigators

  • Principal Investigator: Irfan Wahyudi, MD, PhD, Department of Urology, Faculty of Medicine, Universitas Indonesia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

November 14, 2022

Primary Completion (Anticipated)

June 1, 2023

Study Completion (Anticipated)

December 31, 2023

Study Registration Dates

First Submitted

October 4, 2022

First Submitted That Met QC Criteria

October 4, 2022

First Posted (Actual)

October 6, 2022

Study Record Updates

Last Update Posted (Actual)

October 6, 2022

Last Update Submitted That Met QC Criteria

October 4, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 22-03-0310
  • NKB-1235/UN2.RST/HKP.05.00 (Other Grant/Funding Number: Universitas Indonesia)
  • KET-413/UN2.F1/ETIK/PPM.00.02 (Other Identifier: Faculty of Medicine, University of Indonesia)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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