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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2011 by Advance Shockwave Technology GmbH.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00959153
First Posted: August 14, 2009
Last Update Posted: June 1, 2011
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.
Information provided by:
Advance Shockwave Technology GmbH
  Purpose
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 Intervention Phase
Kidney Stones Device: LithoSpace Extracorporeal Shockwave Lithotripter Phase 3

Study Type: Interventional
Study Design: 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)

Resource links provided by NLM:


Further study details as provided by Advance Shockwave Technology GmbH:

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

Estimated Enrollment: 20
Study Start Date: June 2010
Estimated Study Completion Date: August 2011
Estimated Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Kidney stones
Kidney stones
Device: LithoSpace Extracorporeal Shockwave Lithotripter
Shockwave therapy to break up kidney stones

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00959153


Locations
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
  More Information

Responsible Party: Hugo Stephan, AST
ClinicalTrials.gov Identifier: NCT00959153     History of Changes
Other Study ID Numbers: G080108
First Submitted: August 11, 2009
First Posted: August 14, 2009
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:
Calculi
Kidney Calculi
Nephrolithiasis
Urinary Calculi
Urolithiasis
Pathological Conditions, Anatomical
Kidney Diseases
Urologic Diseases