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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
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