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

Phase 3

• Conditions: Kidney Stones
• Interventions: Device: LithoSpace Extracorporeal Shockwave Lithotripter

• Registration Number: NCT00959153
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-08-11
• Study First Submitted QC: 2009-08-13
• Study First Posted: 2009-08-14
• Study Start: 2010-06
• Status Verified: 2011-05
• Last Update Submitted: 2011-05-31
• Last Update Posted: 2011-06-01
• Primary Completion: 2011-08
• Study Completion: 2011-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Kidney stones	LithoSpace Extracorporeal Shockwave Lithotripter	Kidney stones

Primary Outcome Measures

Name	Time	Method
stone fragmentation	14 days

Trial Locations

Locations (2)

Allied Urological Services, LLC; 🇺🇸 New York, New York, United States

Metropolitan Lithotriptor Associates; 🇺🇸 Garden City, New York, United States