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NCT01514032 Clinical Trial

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

Kidney Stones Clinical Trial

Official title:
TOP-Stone: Treatment of Patients With Small Kidney Stones - Randomized Head-to-head Trial Comparing Extracorporal Shockwave Lithotripsy With Retrograde Intrarenal Surgery

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT01514032
Other study ID # TOP-Stone
Secondary ID
Status Recruiting
Phase N/A
First received January 16, 2012
Last updated January 19, 2012
Start date October 2011
Est. completion date February 2014

Study information
Verified date January 2012
Source University of Zurich
Contact Damian Weber, MD
Phone +41 44 2555407
Email damian.weber@usz.ch
Is FDA regulated No
Health authority Switzerland: Swissmedic
Study type Interventional

Clinical Trial 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

Recruitment information / eligibility
Status Recruiting
Enrollment 230
Est. completion date February 2014
Est. primary completion date February 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Procedure:
• Extracorporal shockwave lithotripsy
Extracorporal shockwave lithotripsy
• Retrograde intrarenal surgery
Retrograde intrarenal surgery

Locations
Country Name City State
Switzerland University Hospital Zurich, Urology Zurich

Sponsors (1)
Lead Sponsor Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome
Type Measure Description Time frame Safety issue
Primary stonefree-rates 3month after therapy 3 month No
See also
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Completed NCT01187745 - Study to Look for Artifact on Computed Tomography (CT) Representing Kidney Stones N/A
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Completed NCT05519150 - Donors With Nephrolithiasis at the Time of Transplant Evaluation (DONATE). Long Term Follow-up.
Recruiting NCT02522689 - Comparison of Ultra-mini PCNL and Micro PCNL N/A
Completed NCT00765128 - Intravenous Ketorolac for Postoperative Pain in Percutaneous Nephrolithotomy Phase 4
Completed NCT00873054 - Percutaneous Nephrolithotomy Versus Extracorporeal Shock Wave Lithotripsy N/A
Withdrawn NCT00583258 - A Randomized Study of Whether Alfuzosin(Xatral) Helps in the Passage of Kidney Stones N/A
Active, not recruiting NCT03630926 - Evaluation of the NV-VPAC1 Prostate Cancer (PCa) Urine Diagnostic Test in Subjects With Biopsy-confirmed Prostate Cancer, Benign Prostatic Hypertrophy, or Bladder/Kidney Stones.
Not yet recruiting NCT02214836 - Ultrasound Imaging of Kidney Stones and Lithotripsy N/A
Completed NCT03095885 - A Pilot Study of Oxalate Absorption in Secondary Hyperoxaluria N/A
Completed NCT01330940 - Effect of Diet Orange Soda on Urinary Lithogenicity N/A
Completed NCT01088555 - Effect of Sodium Thiosulfate on Urine Chemistries of Hypercalciuric Stone Formers N/A
Recruiting NCT00489723 - Is There is a Role of Prophylactic Therapy With Tamsulosin Before Extracorporeal Shock Wave Lithotripsy to Avoid Development of Steinstrasse ? N/A
Recruiting NCT05417568 - Oxalate-Driven Host Responses in Kidney Stone Disease N/A
Recruiting NCT02375295 - Struvite Stones Antibiotic Study Phase 4
Enrolling by invitation NCT02408211 - Preoperative Antibiotic PNL Study Phase 4
Withdrawn NCT01560091 - Differential Effect of Silodosin Versus Tamsulosin on Stone Clearance After Extra-corporeal Shock Wave Lithotripsy Phase 3
Completed NCT00857090 - Pharmacokinetic, Safety and Efficacy Study of OMS201 in Subjects Undergoing Retrograde Ureteroscopic Removal of Upper Urinary Tract Stones Phase 1/Phase 2