NCT06178575

Brief Summary

The goal of this observational study is to developing an image-based artificial intelligence software that can automatically interpret the types and sizes of crystals in urine. The main question\[s\] it aims to answer are:

  • Allowing healthcare professionals to input urine images and receive real-time reading results on crystal types and sizes.
  • This aims to provide a faster, more objective, and accurate analysis of crystals. We anticipate delivering an image AI software suitable for practical applications, promoting the automation and accuracy of urine crystal analysis.

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
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2024

Shorter than P25 for all trials

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 12, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 21, 2023

Completed
11 days until next milestone

Study Start

First participant enrolled

January 1, 2024

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

December 21, 2023

Status Verified

December 1, 2023

Enrollment Period

1 year

First QC Date

December 12, 2023

Last Update Submit

December 12, 2023

Conditions

Keywords

machine learningurinary crystal

Outcome Measures

Primary Outcomes (1)

  • Kappa statistics

    Used for comparing between a new instrument and a standard instrument to determine whether the new instrument exhibits a certain level of performance or accuracy.

    The machine requires approximately 0.5 hours to complete the interpretation of around 800 urine crystal images.

Study Arms (2)

Manual microscopic observation

Control Group: Manual analysis of urine crystal images, distinguishing crystal types, recording accuracy, and analyzing the time consumed.

Machine interpretation

The urine crystal images undergo analysis for crystal types, followed by image preprocessing and category labeling for machine software learning and inference. Subsequently, the interpreted results will be subjected to statistical analysis software to assess accuracy.

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Calcium oxalate kidney stone patient

You may qualify if:

  • Retrospectively analyze the urine crystal images preserved from the previous study 107123-E for crystal type analysis. Subsequently, conduct image preprocessing and label categorization for machine software learning and inference. The interpreted results will then be assessed for accuracy using statistical analysis software.

You may not qualify if:

  • Not applicable

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Kidney Calculi

Condition Hierarchy (Ancestors)

NephrolithiasisKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrolithiasisUrinary CalculiMale Urogenital DiseasesCalculiPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Central Study Contacts

Yi-Shiou Tseng

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Attending physician

Study Record Dates

First Submitted

December 12, 2023

First Posted

December 21, 2023

Study Start

January 1, 2024

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

December 21, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

This study involves retrospectively analyzing urine crystal images preserved from a previous study (Intramural Research Project Code 107123-E at Far Eastern Memorial Hospital). Subsequently, image preprocessing and category labeling will be applied to facilitate machine software learning and inference. The interpreted results will then undergo statistical analysis for accuracy using dedicated software. Participant information and experimental data are stored on a computer in a shared laboratory, with access secured through password protection to ensure data security. Participant identities are encoded for confidentiality. Once the required information is collected, the original participant identities will be linked with their respective codes. Researchers will not obtain the list of potential participants through privacy-invasive means.