Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
NOT YET RECRUITING
NCT07581223
NA

Integrating an AI-Driven Hydronephrosis Decision-Making Tool

Sponsor: The Hospital for Sick Children

View on ClinicalTrials.gov

Summary

Hydronephrosis is a common congenital kidney anomaly. While most cases resolve on their own, some require surgery. Clinicians rely on repeated ultrasounds and sometimes invasive tests to decide if surgery is needed, but predicting outcomes is difficult. Researchers at SickKids developed an AI model that analyzes ultrasound images to assist in diagnosing and managing hydronephrosis. This study tests how well the AI integrates into real-world care. Clinicians will first make care decisions without AI and then review the AI's prediction before deciding whether to change their plan. A separate expert, unaware of whether AI influenced the first clinician's plan, will make the final decision to ensure care remains unchanged. The study will assess whether AI improves decision-making, reduces unnecessary tests, and fits into clinical workflows. If successful, the AI model could serve as a complementary tool to make diagnoses more efficient and precise while minimizing invasive procedures.

Official title: Integration of a Hydronephrosis AI-Driven Decision-Making Tool Into Clinical Practice: A Clinical Trial

Key Details

Gender

All

Age Range

0 Months - 24 Months

Study Type

INTERVENTIONAL

Enrollment

322

Start Date

2026-08-01

Completion Date

2027-01-31

Last Updated

2026-05-12

Healthy Volunteers

No

Interventions

OTHER

Machine learning model

The AI intervention is a deep learning algorithm used to predict obstructive hydronephrosis. It was developed at SickKids and has recently completed the silent trial phase. This clinical trial aims to validate the model's clinical integration by assessing its impact on clinician decision-making and care plan recommendations. To uphold standard care, a blinded clinician will make final decisions.