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Point-of-Care Ultrasonography for Intussusception

NCT03360643 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 256

Last updated 2023-09-01

No results posted yet for this study

Summary

Pediatric emergency medicine (PEM) physicians are increasingly utilizing point-of-care ultrasound (POCUS). There is currently limited data regarding POCUS evaluation for intussusception in pediatric patients. To better understand the role of POCUS for identification of intussusception, the investigators plan to conduct a randomized, noninferiority study comparing POCUS and radiology-performed ultrasound (RADUS), utilizing experienced sonographers across multiple institutions.

Conditions

  • Intussusception
  • Emergencies

Interventions

DIAGNOSTIC_TEST

Point-of-care ultrasound prior to radiology ultrasound

Point-of-care ultrasound performed by pediatric emergency medicine physicians prior to radiology-performed ultrasound

DIAGNOSTIC_TEST

Radiology-performed ultrasound

Ultrasound performed an ultrasound technician and/or radiologist, and interpreted by a radiologist

Sponsors & Collaborators

  • Children's Hospitals and Clinics of Minnesota

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
3 Months
Max Age
6 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-11-15
Primary Completion
2020-07-31
Completion
2021-07-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03360643 on ClinicalTrials.gov