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
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
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Switzerland | University Hospital Zurich, Urology | Zurich |
Lead Sponsor | Collaborator |
---|---|
University of Zurich |
Switzerland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | stonefree-rates 3month after therapy | 3 month | No |
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