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

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ClinicalTrials.gov Identifier: NCT01514032
Recruitment Status : Unknown
Verified January 2012 by University of Zurich.
Recruitment status was:  Recruiting
First Posted : January 20, 2012
Last Update Posted : January 20, 2012
Sponsor:
Information provided by (Responsible Party):
University of Zurich

Study Description
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Brief Summary:

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

Condition or disease Intervention/treatment Phase
Kidney Stones Procedure: Extracorporal shockwave lithotripsy Procedure: Retrograde intrarenal surgery Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 230 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: TOP-Stone: Treatment of Patients With Small Kidney Stones - Randomized Head-to-head Trial Comparing Extracorporal Shockwave Lithotripsy With Retrograde Intrarenal Surgery
Study Start Date : October 2011
Estimated Primary Completion Date : February 2014
Estimated Study Completion Date : February 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Stones
U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Extracorporal shockwave lithotripsy Procedure: Extracorporal shockwave lithotripsy
Extracorporal shockwave lithotripsy
Active Comparator: Retrograde intrarenal surgery Procedure: Retrograde intrarenal surgery
Retrograde intrarenal surgery


Outcome Measures
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Primary Outcome Measures :
  1. stonefree-rates 3month after therapy [ Time Frame: 3 month ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01514032


Contacts
Contact: Damian Weber, MD +41 44 2555407 damian.weber@usz.ch
Contact: Michael Muentener, MD +41 44 2555403 michael.muentener@usz.ch

Locations
Switzerland
University Hospital Zurich, Urology Recruiting
Zurich, Switzerland
Sponsors and Collaborators
University of Zurich
Investigators
Study Director: 01 Studienregister MasterAdmins UniversitaetsSpital Zuerich
Principal Investigator: Michael Muentener, MD University Hospital Zurich, Division of urology
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT01514032     History of Changes
Other Study ID Numbers: TOP-Stone
First Posted: January 20, 2012    Key Record Dates
Last Update Posted: January 20, 2012
Last Verified: January 2012

Additional relevant MeSH terms:
Kidney Calculi
Nephrolithiasis
Kidney Diseases
Urologic Diseases
 Urolithiasis
Urinary Calculi
Calculi
Pathological Conditions, Anatomical