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

Advance Shockwave Technology GmbH20 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Kidney Stones

Interventions

LithoSpace Extracorporeal Shockwave LithotripterDEVICE

Shockwave therapy to break up kidney stones

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (2)

Metropolitan Lithotriptor Associates

Garden City, New York, United States

Allied Urological Services, LLC

New York, New York, United States

Outcomes

Primary Outcomes

stone fragmentation

Time frame: 14 days

Data from ClinicalTrials.gov

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