COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

Extracorporeal Shock Wave Lithotriptor Indicated for Fragmenting Urinary Stones in the Kidney

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00959153
Recruitment Status : Unknown
Verified May 2011 by Advance Shockwave Technology GmbH.
Recruitment status was:  Active, not recruiting
First Posted : August 14, 2009
Last Update Posted : June 1, 2011
Information provided by:
Advance Shockwave Technology GmbH

Brief Summary:
A total of 20 subjects presenting with urinary stone(s) in the kidney or ureter will be treated with an extracorporeal shockwave lithotripsy device to fragment the stones. Subjects will be followed for 14 days. If at the 14 day follow-up visit the subject continues to present with a stone size 4 mm or greater will have an option of retreatment or other intervention. If the subject consents to be retreated at this time, this subject will be followed up for another 14 days.

Condition or disease Intervention/treatment Phase
Kidney Stones Device: LithoSpace Extracorporeal Shockwave Lithotripter Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Extracorporeal Shock Wave Lithotriptor Indicated for Fragmenting Urinary Stones in the Kidney (Renal Pelvis)
Study Start Date : June 2010
Estimated Primary Completion Date : August 2011
Estimated Study Completion Date : August 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Stones Shock

Arm Intervention/treatment
Experimental: Kidney stones
Kidney stones
Device: LithoSpace Extracorporeal Shockwave Lithotripter
Shockwave therapy to break up kidney stones

Primary Outcome Measures :
  1. stone fragmentation [ Time Frame: 14 days ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Diagnosis of a solitary Urinary stones in the renal pelvis or renal calyces or ureter
  • Presence of one stone greater than 4 mm and less than 12 mm

Exclusion Criteria:

  • Urinary tract obstruction, acute or unresolved cholecystitis, cholangitis, pancreatitis or obstruction of the biliary duct system
  • Impaction of stone to be treated
  • Staghorn stones
  • Failed or inadequate lithotripsy procedure within 3 months prior to study
  • Coagulation abnormalities or anticoagulation therapy
  • Pregnant or females of child-bearing potential General, spinal or epidural anesthesia is contraindicated
  • Can not be positioned correctly for fluoroscopic imaging

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00959153

Layout table for location information
United States, New York
Metropolitan Lithotriptor Associates
Garden City, New York, United States, 11530
Allied Urological Services, LLC
New York, New York, United States, 10016
Sponsors and Collaborators
Advance Shockwave Technology GmbH
Layout table for additonal information
Responsible Party: Hugo Stephan, AST Identifier: NCT00959153    
Other Study ID Numbers: G080108
First Posted: August 14, 2009    Key Record Dates
Last Update Posted: June 1, 2011
Last Verified: May 2011
Keywords provided by Advance Shockwave Technology GmbH:
Fragmenting of kidney stones
extracorporeal shockwave lithotripsy
Additional relevant MeSH terms:
Layout table for MeSH terms
Kidney Calculi
Urinary Calculi
Pathological Conditions, Anatomical
Kidney Diseases
Urologic Diseases