This trial is active, not recruiting.

Condition kidney stones
Treatment lithospace extracorporeal shockwave lithotripter
Phase phase 3
Sponsor Advance Shockwave Technology GmbH
Start date June 2010
End date August 2011
Trial size 20 participants
Trial identifier NCT00959153, G080108


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Kidney stones
lithospace extracorporeal shockwave lithotripter
Shockwave therapy to break up kidney stones

Primary Outcomes

stone fragmentation
time frame: 14 days

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Extracorporeal Shock Wave Lithotriptor Indicated for Fragmenting Urinary Stones in the Kidney (Renal Pelvis)
Trial information was received from ClinicalTrials.gov and was last updated in May 2011.
Information provided to ClinicalTrials.gov by Advance Shockwave Technology GmbH.