Extracorporal Shockwave Lithotripsy Versus Retrograde Intrarenal Surgery for the Treatment of Kidney Stones
TOP-Stone: Treatment of Patients With Small Kidney Stones - Randomized Head-to-head Trial Comparing Extracorporal Shockwave Lithotripsy With Retrograde Intrarenal Surgery
1 other identifier
interventional
230
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2011
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2011
CompletedFirst Submitted
Initial submission to the registry
January 16, 2012
CompletedFirst Posted
Study publicly available on registry
January 20, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2014
CompletedJanuary 20, 2012
January 1, 2012
2.3 years
January 16, 2012
January 19, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
stonefree-rates 3month after therapy
3 month
Study Arms (2)
Extracorporal shockwave lithotripsy
ACTIVE COMPARATORRetrograde intrarenal surgery
ACTIVE COMPARATORInterventions
Extracorporal shockwave lithotripsy
Eligibility Criteria
You may qualify if:
- male and female patients between 18 and 99 years
- informed consent signed by patient after explanation of the both treatment-modalities
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospital Zurich, Urology
Zurich, Switzerland
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
01 Studienregister MasterAdmins
UniversitaetsSpital Zuerich
- PRINCIPAL INVESTIGATOR
Michael Muentener, MD
University Hospital Zurich, Division of urology
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 16, 2012
First Posted
January 20, 2012
Study Start
October 1, 2011
Primary Completion
February 1, 2014
Study Completion
February 1, 2014
Last Updated
January 20, 2012
Record last verified: 2012-01