Extracorporal Shockwave Lithotripsy Versus Retrograde Intrarenal Surgery for the Treatment of Kidney Stones

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2012 by University of Zurich.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
University of Zurich
ClinicalTrials.gov Identifier:
NCT01514032
First received: January 16, 2012
Last updated: January 19, 2012
Last verified: January 2012

January 16, 2012
January 19, 2012
October 2011
February 2014   (final data collection date for primary outcome measure)
stonefree-rates 3month after therapy [ Time Frame: 3 month ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01514032 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
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Extracorporal Shockwave Lithotripsy Versus Retrograde Intrarenal Surgery for the Treatment of Kidney Stones
TOP-Stone: Treatment of Patients With Small Kidney Stones - Randomized Head-to-head Trial Comparing Extracorporal Shockwave Lithotripsy With Retrograde Intrarenal Surgery

The purpose of this study is to compare two established modalities for the treatment of kidneystones: ESWL (extracorporal shockwave-lithotripsy) vs. URS (uretero-reno-scopy with stone-extraction). Comparison of the stone-free rates 3month postoperative.

  • Trial with surgical intervention
Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Kidney Stones
  • Procedure: Extracorporal shockwave lithotripsy
    Extracorporal shockwave lithotripsy
  • Procedure: Retrograde intrarenal surgery
    Retrograde intrarenal surgery
  • Active Comparator: Extracorporal shockwave lithotripsy
    Intervention: Procedure: Extracorporal shockwave lithotripsy
  • Active Comparator: Retrograde intrarenal surgery
    Intervention: Procedure: Retrograde intrarenal surgery
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
230
February 2014
February 2014   (final data collection date for primary outcome measure)

Inclusion criteria: - kidneystones requiring treatment up to an maximal size of 15mm (singular or multiple kidneystones with at least one stone with min. 5mm of size)

  • male and female patients between 18 and 99 years
  • informed consent signed by patient after explanation of the both treatment-modalities

Exclusion criteria: - age < 18 or > 99

  • pregnancy
  • breastfeeding mother
  • disorders of blood clotting
  • kidneystones > 15mm
  • aneurysms of the aorta or renal artery
  • severe skeletal deformations which hamper one of the treatment modalities
  • synchronous stones of the ipsilateral ureter
  • stones which can not visualized which X-ray or sonography
Both
18 Years and older
No
Contact: Damian Weber, MD +41 44 2555407 damian.weber@usz.ch
Contact: Michael Muentener, MD +41 44 2555403 michael.muentener@usz.ch
Switzerland
 
NCT01514032
TOP-Stone
Not Provided
University of Zurich
University of Zurich
Not Provided
Study Director: 01 Studienregister MasterAdmins UniversitaetsSpital Zuerich
Principal Investigator: Michael Muentener, MD University Hospital Zurich, Division of urology
University of Zurich
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP