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

Primary Purpose

Kidney Stones

Status
Unknown status
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Extracorporal shockwave lithotripsy
Retrograde intrarenal surgery
Sponsored by
University of Zurich
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Kidney Stones

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital Zurich, UrologyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Extracorporal shockwave lithotripsy

Retrograde intrarenal surgery

Arm Description

Outcomes

Primary Outcome Measures

stonefree-rates 3month after therapy

Secondary Outcome Measures

Full Information

First Posted
January 16, 2012
Last Updated
January 19, 2012
Sponsor
University of Zurich
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1. Study Identification

Unique Protocol Identification Number
NCT01514032
Brief Title
Extracorporal Shockwave Lithotripsy Versus Retrograde Intrarenal Surgery for the Treatment of Kidney Stones
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 Type
Interventional

2. Study Status

Record Verification Date
January 2012
Overall Recruitment Status
Unknown status
Study Start Date
October 2011 (undefined)
Primary Completion Date
February 2014 (Anticipated)
Study Completion Date
February 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Zurich

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Stones

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
230 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Extracorporal shockwave lithotripsy
Arm Type
Active Comparator
Arm Title
Retrograde intrarenal surgery
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Extracorporal shockwave lithotripsy
Intervention Description
Extracorporal shockwave lithotripsy
Intervention Type
Procedure
Intervention Name(s)
Retrograde intrarenal surgery
Intervention Description
Retrograde intrarenal surgery
Primary Outcome Measure Information:
Title
stonefree-rates 3month after therapy
Time Frame
3 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Damian Weber, MD
Phone
+41 44 2555407
Email
damian.weber@usz.ch
First Name & Middle Initial & Last Name or Official Title & Degree
Michael Muentener, MD
Phone
+41 44 2555403
Email
michael.muentener@usz.ch
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
01 Studienregister MasterAdmins
Organizational Affiliation
UniversitaetsSpital Zuerich
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Michael Muentener, MD
Organizational Affiliation
University Hospital Zurich, Division of urology
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Zurich, Urology
City
Zurich
Country
Switzerland
Individual Site Status
Recruiting

12. IPD Sharing Statement

Learn more about this trial

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

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