UrolithiasisPhase 4STONENCT01451931
Study of Tomography of Nephrolithiasis Evaluation
A Phase 4 study testing Point-of-care Ultrasound, Radiology Ultrasound and Radiology CT in people with Urolithiasis, run by University of California, San Francisco at 15 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Urolithiasis
- What is being tested?
- Point-of-care Ultrasound, Radiology Ultrasound and Radiology CT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,776 participants
- Where
- 15 sitesUnited States
- Study dates
- Sep 2011to Sep 2013
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
Grady Memorial Hospital
Atlanta, Georgia, 30303
Massachusetts General Hospital
Boston, Massachusetts, 02114
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
John H. Stroger Jr. Hospital of Cook County
Chicago, Illinois, 60612
UCSF at Fresno
Fresno, California, 93701
University of Texas Houston Medical Center
Houston, Texas, 77026
Hennepin County Medical Center
Minneapolis, Minnesota, 55415
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Oregon Health and Science University
Portland, Oregon, 97239
Rhode Island Hospital
Providence, Rhode Island, 02903
University of California, Davis
Sacramento, California, 95817
University of Utah
Salt Lake City, Utah, 84132
University of California, San Francisco
San Francisco, California, 94143
Washington University School of Medicine
St Louis, Missouri, 63130
Jacobi Medical Center
The Bronx, New York, 10461
About this study
Official title: Randomized Controlled Trial of Ultrasound Versus CT (Computed Tomography) for Patients in the Emergency Department With Suspected Renal Colic
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.
Read the detailed description
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
- Urolithiasis
- Being tested
- Point-of-care Ultrasound, Radiology Ultrasound, Radiology CT
- Keywords
- kidney stone, urolithiasis, urinary tract infection, ultrasound, computed tomography, safety, cost, accuracy
- Medical subject headings
- Urolithiasis, Kidney Calculi, Urinary Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Point-of-care UltrasoundOther
Perform ultrasonography in the ED (physician).
Radiology UltrasoundRadiation
Diagnostic ultrasound completed in the radiology department at time 0.
Radiology CTOther
Computed tomography of abdomen completed in the radiology department at time 0.
| Study group | Role | What they receive |
|---|---|---|
| Point-of-care Ultrasound | Experimental | Patient with suspected urolithiasis will receive ultrasonography performed in the emergency department. Perform ultrasonography in the ED (physician). Receives: Other: Point-of-care Ultrasound |
| Radiology Ultrasound | Experimental | Patient with suspected urolithiasis will receive diagnostic ultrasonography in the radiology department. Diagnostic ultrasound completed in the radiology department at time 0. Receives: Radiation: Radiology Ultrasound |
| Radiology CT | Experimental | Patient with suspected urolithiasis will receive computed tomography in the radiology department. Computed tomography of abdomen completed in the radiology department at time 0. Receives: Other: Radiology CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
High Risk Diagnosis With Complication
Missed or delayed diagnosis of appendicitis, pneumonia with sepsis, diverticulitis, abdominal aortic aneurysm with rupture, mesenteric ischemia with bowel perforation, renal infarction, stone with renal abscess, urosepsis/pyelonephritis with bacteremia, ovarian torsion with necrosis related to randomization and due to imaging modality.
Measured: 30 days from baseline
Cumulative Radiation Exposure
Measured: Baseline plus 6 months post-baseline
Secondary outcomes (3)
ED Length of Stay
Measured: Baseline visit excluding hospitalization
Return Visits to ED or Hospital
Measured: 6 months post-baseline
Accuracy for Stones by Arm
Measured: Up to 6 month follow-up for stone passage
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2011 (estimated)
- Study startSep 2011
- Primary completionSep 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for UrolithiasisStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,776 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rebecca Smith-Bindman, MD, Principal investigator, University of California, San Francisco, Department of Radiology and Biomedical ImagingClifford Rosen, MD, Study chair, Professor of Medicine, Tufts University (Data Safety Monitoring Board Chair)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01451931
- Sponsor's protocol ID
- RSB-1002670
- Acronym
- STONE
- Status last verified
- Dec 2014
- First submitted
- 11 Oct 2011
- Last updated
- 3 Dec 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of Ultrasound Versus CT (Computed Tomography) for Patients in the Emergency Department With Suspected Renal Colic
- ClinicalTrials.gov ID
- NCT01451931
- Acronym / sponsor ID
- STONE / RSB-1002670
- Conditions
- Urolithiasis
- Keywords
- kidney stone, urolithiasis, urinary tract infection, ultrasound, computed tomography, safety, cost, accuracy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,776 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 14 Oct 2011 (estimated)
- Results
- Posted 3 Dec 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Point-of-care Ultrasound | Experimental | Other: Point-of-care UltrasoundPatient with suspected urolithiasis will receive ultrasonography performed in the emergency department. Perform ultrasonography in the ED (physician). |
| Radiology Ultrasound | Experimental | Radiation: Radiology UltrasoundPatient with suspected urolithiasis will receive diagnostic ultrasonography in the radiology department. Diagnostic ultrasound completed in the radiology department at time 0. |
| Radiology CT | Experimental | Other: Radiology CTPatient with suspected urolithiasis will receive computed tomography in the radiology department. Computed tomography of abdomen completed in the radiology department at time 0. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (6 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Point-of-care UltrasoundPerform ultrasonography in the ED (physician). | Other | Point-of-care Ultrasound |
| Radiology UltrasoundDiagnostic ultrasound completed in the radiology department at time 0. | Radiation | Radiology Ultrasound |
| Radiology CTComputed tomography of abdomen completed in the radiology department at time 0. | Other | Radiology CT |
Primary outcome
High Risk Diagnosis With Complication
Time frame: 30 days from baseline
Missed or delayed diagnosis of appendicitis, pneumonia with sepsis, diverticulitis, abdominal aortic aneurysm with rupture, mesenteric ischemia with bowel perforation, renal infarction, stone with renal abscess, urosepsis/pyelonephritis with bacteremia, ovarian torsion with necrosis related to randomization and due to imaging modality.
Cumulative Radiation Exposure
Time frame: Baseline plus 6 months post-baseline
3 secondary outcomes
ED Length of Stay
Time frame: Baseline visit excluding hospitalization
Return Visits to ED or Hospital
Time frame: 6 months post-baseline
Accuracy for Stones by Arm
Time frame: Up to 6 month follow-up for stone passage
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Urolithiasis
Enrolling by invitationObservational study
Renal Structural and Functional Alterations Following Repeated Ureteroscopic Procedures: An Exploratory Multimodal Imaging Study
Urolithiasis, Intrarenal Pressure
RecruitingObservational study
Stone Clearance With Aspiration vs Other Technologies: a Real-world Evidence Study
Urolithiasis, Stones, Kidney
Not yet recruiting
Intertransverse Process Block Versus Erector Spinae Plane Block for Postoperative Analgesia After Percutaneous Nephrolithotomy
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Recruiting
Trial of Ureteroscopy vs Steerable Continuous Flow Aspiration Technology
Urolithiasis, Stones, Kidney
Active, not recruitingObservational study
A Retrospective, Multi-center Real-world Study of Steerable Ureteroscopic Renal Evacuation (SURE) Procedure With the CVAC® System
Urolithiasis, Kidney Stone
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rebecca Smith-Bindman, MD principal investigator
University of California, San Francisco, Department of Radiology and Biomedical Imaging
Clifford Rosen, MD study chair
Professor of Medicine, Tufts University (Data Safety Monitoring Board Chair)
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Point-of-care Ultrasound, Radiology Ultrasound and Radiology CT in people with Urolithiasis, run by University of California, San Francisco at 15 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Dec 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
High Risk Diagnosis With Complication (time frame: 30 days from baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2014; AzTrials last refreshed its copy on 6 Nov 2026.