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

Sponsor

Advance Shockwave Technology GmbH (Industry)

Overall Status

Unknown status

CT.gov ID

NCT00959153

Collaborator

(none)

Enrollment

Locations

Arm

Duration (Months)

Patients Per Site

0.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Kidney Stones	Device: LithoSpace Extracorporeal Shockwave Lithotripter	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Extracorporeal Shock Wave Lithotriptor Indicated for Fragmenting Urinary Stones in the Kidney (Renal Pelvis)

Study Start Date :

Jun 1, 2010

Anticipated Primary Completion Date :

Aug 1, 2011

Anticipated Study Completion Date :

Aug 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Kidney stones Kidney stones	Device: LithoSpace Extracorporeal Shockwave Lithotripter Shockwave therapy to break up kidney stones

Arm

Intervention/Treatment

Experimental: Kidney stones

Kidney stones

Device: LithoSpace Extracorporeal Shockwave Lithotripter

Shockwave therapy to break up kidney stones

Outcome Measures

Primary Outcome Measures

stone fragmentation [14 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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