Contrast Ultrasound for Pediatric Trauma - Comparative Evaluation (CAPTURE) Study
Study ID: STU-2020-1359
Summary
To address the primary objective, we propose a multi-center study with participation from 5 to 10 sites to enroll 100 subjects to the study test phase, with a maximum of 20 enrolled patients per site. Up to 30 additional patients will be enrolled in an initial training phase, with a maximum of 3 enrolled patients per site, for a total of 130 enrolled patients for the study. All subjects will be age 8-18 years inclusive and enrolled over a period of 18 to 36 months.
Cardiovascular; Gall Bladder; Kidney; Liver; Pancreas; Soft Tissue
The primary goal of the study is to evaluate whether the use of ultrasound contrast can improve concordance of ultrasound with the gold-standard CT in diagnosing abdominal solid organ injuries in pediatric patients, thereby making it a valuable diagnostic tool.