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Study of Tomography of Nephrolithiasis Evaluation

NCT ID: NCT01451931

Last Updated: 2014-12-03

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

2776 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2013-09-30

Brief Summary

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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.

Detailed Description

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This is a multi-center, randomized controlled trial of ultrasonography compared with computed tomography (CT) for the evaluation of patients with suspected urolithiasis. The study will be conducted at 15 large urban Emergency Departments (EDs), reflecting geographic, socioeconomic, racial and ethnic diversity, and include academic medical centers as well as safety net hospitals. The patients will be randomized to one of three arms: 1) ultrasound in the Emergency Department (ED), 2) ultrasound in radiology or 3) CT in radiology. The investigators will then collect precise and unbiased data on a comprehensive range of outcomes that will allow assessment of effectiveness, safety, accuracy and cost between patients randomized to one the three groups. Taken together, these measures are intended to provide the basis for a valid comparison of imaging of patients with suspected urolithiasis seen in the ED. The results of this trial could lead to a change in clinical practice that is associated with both improved patient outcomes and reduced cost. Broad stakeholder involvement from within radiology, emergency medicine and several subspecialty communities has been sought to ensure the strategic completion of study aims and to help rapidly disseminate the results of the study into clinical practice. This will create a collaborative network of EDs willing to act as a laboratory for studying the comparative effectiveness of diagnostic testing. As a result, the proposed trial will demonstrate the feasibility of conducting Randomized Control Trials (RCTs) of imaging that incorporates measurements of outcomes that can be expanded to additional imaging tests in the future.

Conditions

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Urolithiasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Point-of-care Ultrasound

Patient with suspected urolithiasis will receive ultrasonography performed in the emergency department. Perform ultrasonography in the ED (physician).

Group Type EXPERIMENTAL

Point-of-care Ultrasound

Intervention Type OTHER

Perform ultrasonography in the ED (physician).

Radiology Ultrasound

Patient with suspected urolithiasis will receive diagnostic ultrasonography in the radiology department. Diagnostic ultrasound completed in the radiology department at time 0.

Group Type EXPERIMENTAL

Radiology Ultrasound

Intervention Type RADIATION

Diagnostic ultrasound completed in the radiology department at time 0.

Radiology CT

Patient with suspected urolithiasis will receive computed tomography in the radiology department. Computed tomography of abdomen completed in the radiology department at time 0.

Group Type EXPERIMENTAL

Radiology CT

Intervention Type OTHER

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

Interventions

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Point-of-care Ultrasound

Perform ultrasonography in the ED (physician).

Intervention Type OTHER

Radiology Ultrasound

Diagnostic ultrasound completed in the radiology department at time 0.

Intervention Type RADIATION

Radiology CT

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* men or women = or \>18 but \<76 years of age presenting with acute renal colic
* Emergency department physician highly suspects a primary diagnosis of kidney stones (renal colic) or the patient requires imaging to rule out kidney stones.

Exclusion Criteria

* children \< 18 years old
* elderly patients \> or = 76 years old
* pregnancy or planning pregnancy
* Morbid obesity (\>285 pounds in men, \>250 pounds in women)
* patients with an acute abdomen, signs of sepsis, signs of alternate diagnosis (ie appendicitis, abdominal aortic aneurysm, pyelonephritis, kidney stones not suspected).
* history of kidney problems (hemodialysis, kidney transplant, presence of only one kidney)
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of California, San Francisco

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Rebecca Smith-Bindman, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco, Department of Radiology and Biomedical Imaging

Clifford Rosen, MD

Role: STUDY_CHAIR

Professor of Medicine, Tufts University (Data Safety Monitoring Board Chair)

Locations

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UCSF at Fresno

Fresno, California, United States

Site Status

University of California, Davis

Sacramento, California, United States

Site Status

University of California, San Francisco

San Francisco, California, United States

Site Status

Grady Memorial Hospital

Atlanta, Georgia, United States

Site Status

John H. Stroger Jr. Hospital of Cook County

Chicago, Illinois, United States

Site Status

Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Site Status

Hennepin County Medical Center

Minneapolis, Minnesota, United States

Site Status

Washington University School of Medicine

St Louis, Missouri, United States

Site Status

Jacobi Medical Center

The Bronx, New York, United States

Site Status

Oregon Health and Science University

Portland, Oregon, United States

Site Status

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

Rhode Island Hospital

Providence, Rhode Island, United States

Site Status

University of Texas Houston Medical Center

Houston, Texas, United States

Site Status

University of Utah

Salt Lake City, Utah, United States

Site Status

Countries

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United States

Other Identifiers

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RSB-1002670

Identifier Type: -

Identifier Source: org_study_id