Extracorporeal Shock Wave Lithotriptor Indicated for Fragmenting Urinary Stones in the Kidney (Renal Pelvis)

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

Sponsors

Lead sponsor: Advance Shockwave Technology GmbH

Source 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.

Overall Status Unknown status
Start Date June 2010
Completion Date August 2011
Primary Completion Date August 2011
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
stone fragmentation 14 days
Enrollment 20
Condition
Intervention

Intervention type: Device

Intervention name: LithoSpace Extracorporeal Shockwave Lithotripter

Description: Shockwave therapy to break up kidney stones

Arm group label: Kidney stones

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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: Accepts Healthy Volunteers

Location
facility
Metropolitan Lithotriptor Associates | Garden City, New York, 11530, United States
Allied Urological Services, LLC | New York, New York, 10016, United States
Location Countries

United States

Verification Date

May 2011

Responsible Party

Name title: Hugo Stephan

Organization: AST

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Arm group label: Kidney stones

Arm group type: Experimental

Description: Kidney stones

Study Design Info

Allocation: Non-Randomized

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov