Kidney Stones
Conditions
Keywords
Fragmenting of kidney stones, extracorporeal shockwave lithotripsy
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.
Interventions
DEVICELithoSpace Extracorporeal Shockwave Lithotripter
Shockwave therapy to break up kidney stones
Sponsors
Advance Shockwave Technology GmbH
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| stone fragmentation | 14 days |
Countries
United States
Outcome results
None listed