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

NCT ID: NCT00959153

Last Updated: 2011-06-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-06-30
• Study Completion Date: 2011-08-31

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.

Conditions

Kidney Stones

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Kidney stones

Kidney stones

Group Type: EXPERIMENTAL

LithoSpace Extracorporeal Shockwave Lithotripter

Intervention Type: DEVICE

Shockwave therapy to break up kidney stones

Interventions

LithoSpace Extracorporeal Shockwave Lithotripter

Shockwave therapy to break up kidney stones

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Advance Shockwave Technology GmbH

INDUSTRY

Sponsor Role: lead

Responsible Party

AST

Locations

Metropolitan Lithotriptor Associates

Garden City, New York, United States

Allied Urological Services, LLC

New York, New York, United States

Countries

United States

Other Identifiers

G080108

Identifier Type: -

Identifier Source: org_study_id