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
Recruitment status was Recruiting
Sponsor:
University of Zurich
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
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Purpose
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 | Intervention |
|---|---|
|
Kidney Stones |
Procedure: Extracorporal shockwave lithotripsy Procedure: Retrograde intrarenal surgery |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: 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 |
Resource links provided by NLM:
Further study details as provided by University of Zurich:
Primary Outcome Measures:
- stonefree-rates 3month after therapy [ Time Frame: 3 month ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 230 |
| Study Start Date: | October 2011 |
| Estimated Study Completion Date: | February 2014 |
| Estimated Primary Completion Date: | February 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: Extracorporal shockwave lithotripsy |
Procedure: Extracorporal shockwave lithotripsy
Extracorporal shockwave lithotripsy
|
| Active Comparator: Retrograde intrarenal surgery |
Procedure: Retrograde intrarenal surgery
Retrograde intrarenal surgery
|
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Genders Eligible for Study: | Both |
| 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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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01514032
Please refer to this study by its ClinicalTrials.gov identifier: 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
| Responsible Party: | University of Zurich |
| ClinicalTrials.gov Identifier: | NCT01514032 History of Changes |
| Other Study ID Numbers: | TOP-Stone |
| Study First Received: | January 16, 2012 |
| Last Updated: | January 19, 2012 |
| Health Authority: | Switzerland: Swissmedic |
Additional relevant MeSH terms:
|
Kidney Calculi Nephrolithiasis Kidney Diseases Urologic Diseases |
Urolithiasis Urinary Calculi Calculi Pathological Conditions, Anatomical |
ClinicalTrials.gov processed this record on September 30, 2016