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

Kidney Stones Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00959153
• Other study ID #: G080108
• Status: Active, not recruiting
• Phase: Phase 3
• First received: August 11, 2009
• Last updated: May 31, 2011
• Start date: June 2010
• Est. completion date: August 2011

Study information

• Verified date: May 2011
• Source: Advance Shockwave Technology GmbH
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: August 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Calculi
• Kidney Calculi
• Kidney Stones
• Nephrolithiasis
• Urinary Calculi

Intervention

Device:
• LithoSpace Extracorporeal Shockwave Lithotripter
Shockwave therapy to break up kidney stones

Locations

Country	Name	City	State
United States	Metropolitan Lithotriptor Associates	Garden City	New York
United States	Allied Urological Services, LLC	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Advance Shockwave Technology GmbH

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	stone fragmentation		14 days	Yes