Study of Tomography of Nephrolithiasis Evaluation

Status Completed

Clinical 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. 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.

Clinical Trial 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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

Urolithiasis

Clinical Trial Details

NCT number	NCT01451931
Study type	Interventional
Source	University of California, San Francisco
Contact
Status	Completed
Phase	Phase 4
Start date	September 2011
Completion date	September 2013

View Details

See also
Status	Clinical Trial	Phase
Enrolling by invitation	`NCT04746378` - PRedictive Accuracy of Initial Stone Burden Evaluation.
Recruiting	`NCT05100017` - Methocarbamol vs Oxybutynin for Management of Pain and Discomfort S/P Ureteroscopy Procedure	N/A
Recruiting	`NCT04021381` - Citrate Salts for Stone-free Result After Flexible Ureterorenoscopy for Inferior Calyx Calculi	Phase 3
Completed	`NCT02266381` - A Prospective Comparison of Fluoroscopic, Sonographic or Combined Approach for Renal Access in Percutaneous Nephrolithotomy	N/A
Terminated	`NCT01431378` - Pilot Study of Model Based Iterative Reconstruction Using 64-Slice	N/A
Completed	`NCT02895711` - Radiation Dose of Pediatric Patients During Ureteroscopy
Completed	`NCT01295879` - Vitamin D Repletion in Stone Formers With Hypercalciuria	Phase 4
Completed	`NCT05340075` - Staged Bilateral Percutaneous Nephrolithotomy
Recruiting	`NCT03919227` - Measurement of Resistance During UAS Insertion Procedure in RIRS	N/A
Recruiting	`NCT03717285` - Under Direct Vision vs Under Non Direct Vision of Insertion of UAS in RIRS	N/A
Completed	`NCT05340088` - Optimal Passive Dilation Time in Retrograde Intrarenal Surgery
Completed	`NCT05032287` - Medical Expulsive Therapy Post-SWL For Renal Stones	N/A
Recruiting	`NCT05701098` - SOUND Pivotal Trial - (Sonomotion stOne comminUtion resoNance ultrasounD)	N/A
Not yet recruiting	`NCT04080973` - Metabolic Workup in Patients Suffering From Kidney Stone Disease and Osteopenia	N/A
Terminated	`NCT01736358` - The Use of Intranasal Ketoralac for Pain Management (Sprix)	Phase 4
Completed	`NCT01792765` - Management of Ureteral Calculi Using Ultrasound Guidance: A Radiation Free Approach	N/A
Completed	`NCT06211842` - Genetic Variations That Increase the Risk for Calcium Kidney Stones: a Family-based Study
Not yet recruiting	`NCT02214836` - Ultrasound Imaging of Kidney Stones and Lithotripsy	N/A
Not yet recruiting	`NCT04606758` - Fluoroscopic Guided vs US-guided Percutaneous Nephrolithotripsy for the Treatment of Stone Disease	N/A
Terminated	`NCT01873690` - Efficacy of Antimicrobial Prophylaxis for Shock Wave Lithotripsy (SWL) on Reducing Urinary Tract Infection (UTI)	Phase 3

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Study of Tomography of Nephrolithiasis Evaluation — STONE

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms