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

Advance Shockwave Technology

Status and phase: Unknown; Phase 3

Conditions: Kidney Stones

Treatments: Device: LithoSpace Extracorporeal Shockwave Lithotripter

Study type: Interventional

Funder types: Industry

Identifiers

NCT00959153

G080108

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Kidney stones

Experimental group

Description:

Kidney stones

Treatment:

Device: LithoSpace Extracorporeal Shockwave Lithotripter