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
Sponsor:
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
  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
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. 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

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

No publications provided

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:
Calculi
Kidney Calculi
Nephrolithiasis
Pathological Conditions, Anatomical
Kidney Diseases
Urologic Diseases
Urolithiasis
Urinary Calculi

ClinicalTrials.gov processed this record on October 19, 2014