The Study Aims to Improve the Accuracy of Detecting Spina Bifida During Early Ultrasound Scans. to Achieve This, an AI Model Has Been Developed to Provide Feedback About the Presence of Spina Bifida. a RCT Has Been Designed to Compare the Effectiveness of AI Feedback with No AI Feedback.

December 2, 2024 updated by: Julie Leth-Petersen, Copenhagen Academy for Medical Education and Simulation

Evaluation of XAI-assisted Spina Bifida Diagnosis

The study aims to improve the accuracy of detecting spina bifida during early ultrasound scans. To achieve this, an AI model has been developed to provide feedback about the presence of spina bifida. A RCT has been designed to compare the effectiveness of AI feedback with no AI feedback.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The study aims to improve the accuracy of detecting spina bifida during early ultrasound scans. To achieve this, an AI model has been developed to provide feedback about the presence of spina bifida. A randomized controlled trial (RCT) has been designed to compare the effectiveness of AI feedback with no AI feedback. Forty fetal medicine specialists are randomly assigned to receive either the AI feedback or no feedback, and the two groups are compared to determine if the feedback improved the accuracy of detecting spina bifida.

Study Type

Interventional

Enrollment (Actual)

38

Phase

  • Not Applicable

Contacts and Locations

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

Study Locations

  • Denmark
      • Copenhagen, Denmark
        • Copenhagen University Hospital, Rigshospitalet

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Obstetricians

Exclusion Criteria:

  • Fetal medicine specialists

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

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: AI feedback
The participant will receive AI feedback upon completing the task of analyzing 20 images. The AI feedback will include a prediction (Normal/Spina Bifida) along with a confidence score ranging from 0.0 to 1.0, where 0.0 indicates the lowest confidence and 1.0 indicates the highest confidence.
Other: Evaluation of XAI-assisted spina bifida diagnosis
AI feedback
Placebo Comparator: No AI feedback
The participants will complete the task of analyzing 20 images without any AI feedback.
Other: Evaluation of XAI-assisted spina bifida diagnosis
AI feedback

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of XAI-assisted spina bifida diagnosis
Time Frame: One month after the survey is distributed.
The study aims to evaluate whether AI feedback improve the accuracy of diagnosing spina bifida by comparing the number of correct and incorrect responses in a task involving 20 images.
One month after the survey is distributed.

Collaborators and Investigators

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

Sponsor

Copenhagen Academy for Medical Education and Simulation

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 (Actual)

July 1, 2024

Primary Completion (Actual)

October 30, 2024

Study Completion (Actual)

October 30, 2024

Study Registration Dates

First Submitted

May 22, 2024

First Submitted That Met QC Criteria

August 20, 2024

First Posted (Actual)

August 22, 2024

Study Record Updates

Last Update Posted (Estimated)

December 4, 2024

Last Update Submitted That Met QC Criteria

December 2, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P-2019-310

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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