Clinical Trials Logo
  1. Home
  2. Abdominal Injury
  3. NCT03147690

Contrast-Enhanced Ultrasound in the Evaluation of Abdominal Injuries in Children

Abdominal Injury Clinical Trial

Official title:
A Multicenter Trial of Contrast-Enhanced Ultrasound in the Evaluation of Abdominal Solid Organ Injuries in Pediatric Trauma

Clinical Trial Summary

This study proposes to evaluate the accuracy of contrast-enhanced ultrasound (CEUS) in diagnosing abdominal solid organ injuries in pediatric patients. 146 subjects will be enrolled across approximately 8 sites in the US. All subjects will have had a Computerized Tomography (CT) scan as part of standard of care, confirming at least one solid organ abdominal injury. All subjects will have an abdominal ultrasound without contrast, followed by a contrast-enhanced ultrasound using the contrast agent Lumason. Ultrasound and contrast-enhanced ultrasound results will be compared to the CT scan results. The study procedures will take place within 48 hours of injury.

Clinical Trial Description

This is an interventional study proposes to evaluate the accuracy of contrast-enhanced ultrasound (CEUS) in diagnosing abdominal solid organ injuries in pediatric patients. 146 subjects will be enrolled across approximately 8 sites in the US. All subjects will have had a Computerized Tomography (CT) scan as part of standard of care, confirming at least one solid organ abdominal injury. All subjects will have an abdominal ultrasound without contrast, followed by a contrast-enhanced ultrasound using the contrast agent Lumason. Ultrasound and contrast-enhanced ultrasound results will be compared to the CT scan results. The study procedures will take place within 48 hours of injury. At conclusion of enrollment of all subjects a centralized review of CT vs. CEUS will occur to compare to real time readings. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03147690
Study type Interventional
Source Boston Children's Hospital
Contact
Status Terminated
Phase Phase 1/Phase 2
Start date November 1, 2017
Completion date October 7, 2019
View Details
See also
  Status Clinical Trial Phase
Active, not recruiting NCT04718441 - Contrast Ultrasound for Pediatric Trauma - Comparative Evaluation (CAPTURE Study) Phase 1/Phase 2
Completed NCT04865627 - Accuracy Activity Monitors for Inhospital Activity Monitoring of Geriatric Patients
Completed NCT03109483 - Effectiveness of the Geriatric Activation Program Pellenberg (GAPP) on the Geriatric Rehabilitation Ward N/A
Completed NCT04058015 - Outcome of Patients With Thoraco-abdominal Injury and Stress-induced Hyperglycemia or Diabetic Hyperglycemia
Completed NCT04978090 - Pilot Study Evaluating the Safety and Efficacy of a Patient-Specific Enteroatmospheric Fistula Isolation and Management Device Independent of Negative Pressure Wound Therapy N/A
Completed NCT03515811 - A Post Market Study to Confirm the Safety and Performance of the Signia™ Stapling System.
Recruiting NCT04937868 - Developing a Decision Instrument to Guide Abdominal-pelvic CT Imaging of Blunt Trauma Patients
Completed NCT04282291 - Serratus Intercostal Plane Block,New Analgesia in Supraumbilical Surgery
Recruiting NCT05910567 - A Research Study of Abdominal Ultrasound (FAST) in Children With Blunt Torso Trauma N/A
Recruiting NCT03815370 - A Non-Traumatic Binder for Temporary Abdominal Wall Closure N/A