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

Primary Purpose

Kidney Stones

Status
Unknown status
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
LithoSpace Extracorporeal Shockwave Lithotripter
Sponsored by
Advance Shockwave Technology GmbH
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Kidney Stones focused on measuring Fragmenting of kidney stones, extracorporeal shockwave lithotripsy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Metropolitan Lithotriptor Associates
  • Allied Urological Services, LLC

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Kidney stones

Arm Description

Kidney stones

Outcomes

Primary Outcome Measures

stone fragmentation

Secondary Outcome Measures

Full Information

First Posted
August 11, 2009
Last Updated
May 31, 2011
Sponsor
Advance Shockwave Technology GmbH
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1. Study Identification

Unique Protocol Identification Number
NCT00959153
Brief Title
Extracorporeal Shock Wave Lithotriptor Indicated for Fragmenting Urinary Stones in the Kidney
Official Title
Extracorporeal Shock Wave Lithotriptor Indicated for Fragmenting Urinary Stones in the Kidney (Renal Pelvis)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2011
Overall Recruitment Status
Unknown status
Study Start Date
June 2010 (undefined)
Primary Completion Date
August 2011 (Anticipated)
Study Completion Date
August 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Advance Shockwave Technology GmbH

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Stones
Keywords
Fragmenting of kidney stones, extracorporeal shockwave lithotripsy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Kidney stones
Arm Type
Experimental
Arm Description
Kidney stones
Intervention Type
Device
Intervention Name(s)
LithoSpace Extracorporeal Shockwave Lithotripter
Intervention Description
Shockwave therapy to break up kidney stones
Primary Outcome Measure Information:
Title
stone fragmentation
Time Frame
14 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
Metropolitan Lithotriptor Associates
City
Garden City
State/Province
New York
ZIP/Postal Code
11530
Country
United States
Facility Name
Allied Urological Services, LLC
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States

12. IPD Sharing Statement

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

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