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Study of Tomography of Nephrolithiasis Evaluation

NCT01451931 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 2776

Last updated 2014-12-03

Study results available
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Summary

This is a multi-center, randomized controlled trial of ultrasonography (ultrasound) compared to computed tomography (CT) for the initial emergency room evaluation of patients with suspected renal colic. The investigators will compare several measures of effectiveness including morbidity related to the patient's underlying disease, or complications related to delayed diagnosis, patient status regarding pain/missed days of work, and utilization of health care resources based on one of three study arms: ultrasound in the Emergency Department, ultrasound in Radiology or CT.

Conditions

  • Urolithiasis

Interventions

OTHER

Point-of-care Ultrasound

Perform ultrasonography in the ED (physician).

RADIATION

Radiology Ultrasound

Diagnostic ultrasound completed in the radiology department at time 0.

OTHER

Radiology CT

Computed tomography of abdomen completed in the radiology department at time 0.

Sponsors & Collaborators

Principal Investigators

  • Rebecca Smith-Bindman, MD · University of California, San Francisco, Department of Radiology and Biomedical Imaging

  • Clifford Rosen, MD · Professor of Medicine, Tufts University (Data Safety Monitoring Board Chair)

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-09-30
Primary Completion
2013-09-30
Completion
2013-09-30

Countries

  • United States

Study Locations

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Entities

Companies

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 NCT01451931 on ClinicalTrials.gov