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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2011 by Advance Shockwave Technology GmbH.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Advance Shockwave Technology GmbH
ClinicalTrials.gov Identifier:
NCT00959153
First received: August 11, 2009
Last updated: May 31, 2011
Last verified: May 2011
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Hugo Stephan, AST
ClinicalTrials.gov Identifier: NCT00959153     History of Changes
Other Study ID Numbers: G080108
Study First Received: August 11, 2009
Last Updated: May 31, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Advance Shockwave Technology GmbH:
Fragmenting of kidney stones
extracorporeal shockwave lithotripsy

Additional relevant MeSH terms:
Calculi
Kidney Calculi
Nephrolithiasis
Urinary Calculi
Pathological Conditions, Anatomical
Kidney Diseases
Urologic Diseases
Urolithiasis

ClinicalTrials.gov processed this record on April 16, 2014