CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 35 enrolled
Drug / intervention
Butterfly IQdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05870345
NCT05870345N/ACompleted

The Diagnostic Accuracy of Pocket Size Ultrasound (PsUS) in the Detection of Pediatric Elbow Fractures

University of Chicago·interventional·Posted May 23, 2023·Updated Jun 20, 2024

In Brief

A clinical study evaluating Butterfly IQ for Elbow Injury and Elbow Fracture. Completed, enrolled 35 participants across 1 site.

Detailed Summary

The main purpose of this project is to investigate the accuracy of pocket-sized ultrasound (PsUS) in the diagnosis of pediatric elbow fractures. The primary research objective is to determine the test performance characteristics of PSUS performed by pediatric emergency medicine physicians compared to radiography for the detection of pediatric elbow fractures. The project will consist of two parts, first involving a feasibility study and followed by an active study. The feasibility study will aim to answer if providers can perform an adequate elbow ultrasound exam after a brief study training. The active study will investigate the initial accuracy of the PsUS. Participants will be asked in either the feasibility or the active phases of the study to undergo a brief pocket-sized ultrasound elbow exam of both elbows. Patient will continue to receive their previously determined clinical ED management. In the active phase of the study, participant's elbow X-rays or if patient underwent bedside nursemaid reduction will be the comparison to pocket-sized ultrasound images.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20222023202420252026
First PostedMay 23, 2023
Enrollment StartJan 18, 2022
Primary CompletionMay 5, 2023
Study CompletionJun 7, 2023
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 3.1 years ago

Interventions

Butterfly IQdevice

Butterfly IQ is a pocket sized ultrasound device. Each participant will undergo a ultrasound exam of both elbows using a pocket sized ultrasound device.