CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 104 enrolled
Drug / intervention
SWL - Compact Delta Dornier Med Techdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01589484
NCT01589484N/ACompleted

Impact of Renal Anatomy on Shock Wave Lithotripsy Outcomes for Lower Pole Kidney Stones: Results From a Prospective Multifactorial Analysis

University of Sao Paulo·interventional·Posted May 2, 2012·Updated Jan 7, 2015

In Brief

A clinical study evaluating SWL - Compact Delta Dornier Med Tech for Urolithiasis and 2 related conditions. Completed, enrolled 104 participants across 1 site.

Detailed Summary

Kidney stone disease affects almost 10% of overall population, often requiring a surgical intervention. Currently, shock wave lithotripsy is considered a first-line treatment option for patients suffering from symptomatic kidney stones smaller than 2.0 cm, providing reasonable stone-free rate. Actually, the outcomes from SWL vary largely due to several factors including stone burden, stone density, stone-skin distance (SSD), and patient's body habitus. Furthermore, the imaging exam modality (i.e. ultrasound versus computed tomography scan) performed to assess the presence of residual fragments also impacts on SWL outcome analysis. We aim to perform a well-controlled prospective evaluation of all variables that may impact on fragmentation and clearance of lower pole calculi after SWL. These variables are assessed exclusively by a noncontrast computed tomography scan (NCCT), eliminating the necessity of an intravenous urography to study renal collecting system anatomy; an imaging exam that is not routinely performed anymore for kidney stone patients.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesBrazil
Collaborators--

Timeline

N/ACompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedMay 2, 2012
Enrollment StartApr 1, 2012
Primary CompletionAug 1, 2014
Study CompletionDec 1, 2014
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 14.2 years ago

Interventions

SWL - Compact Delta Dornier Med Techdevice

All patients will be submitted to a noncontrast computed tomography before to SWL. Patients will be submitted to SWL under the following conditions: outpatient, general anesthesia, 3000 impulses, rate of 90/min, discharged from hospital in the same day with alpha-blocker (doxazosin) during 30 days.