MedDataX Logo

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.

NCT ID: NCT06566014

Last Updated: 2024-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-01

Study Completion Date

2024-10-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Spina Bifida

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Evaluation of XAI-assisted spina bifida diagnosis

Intervention Type OTHER

AI feedback

No AI feedback

The participants will complete the task of analyzing 20 images without any AI feedback.

Group Type PLACEBO_COMPARATOR

Evaluation of XAI-assisted spina bifida diagnosis

Intervention Type OTHER

AI feedback

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Evaluation of XAI-assisted spina bifida diagnosis

AI feedback

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Obstetricians

Exclusion Criteria

* Fetal medicine specialists
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Copenhagen Academy for Medical Education and Simulation

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Julie Leth-Petersen

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Copenhagen University Hospital, Rigshospitalet

Copenhagen, , Denmark

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Denmark

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

P-2019-310

Identifier Type: -

Identifier Source: org_study_id