The purpose of this study is to evaluate the safety and performance of the ELS to treat urinary stones. The ELS is intended to break urinary stones into small fragments that can pass during or after the procedure with less or no discomfort. Eligible patients are male or females, age 21 or older, with a single urinary stone in the ureter. Participants will undergo the ELS procedure and then be evaluated 30 days later for the presence or absence of urinary stone fragments on a CT scan. Subjects who still have stone present at Day 30 will be evaluated again at Day 60. Other outcome measures will be changes in pain, quality of life, and return to normal daily activities/work.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
101
ELS (Enhanced Lithotripsy System) utilizes low pressure ultrasound to actuate proprietary microbubbles administered into the urine to pit and fragment urinary stones.
Arizona State Urological Research Institute
Phoenix, Arizona, United States
RECRUITINGArkansas Urology Research Center
Little Rock, Arkansas, United States
ENROLLING_BY_INVITATIONMichael G. Oefelein Clinical Trials
Bakersfield, California, United States
ACTIVE_NOT_RECRUITINGSan Diego Clinical Trials
La Mesa, California, United States
RECRUITINGGolden State Urology
Sacramento, California, United States
RECRUITINGUniversity of Miami Hospital
Miami, Florida, United States
RECRUITINGGeorgia Urology
Roswell, Georgia, United States
RECRUITINGComprehensive Urologic Care
Lake Barrington, Illinois, United States
RECRUITINGWichita Urology Group
Wichita, Kansas, United States
RECRUITINGMinnesota Urology
Woodbury, Minnesota, United States
RECRUITING...and 10 more locations
Primary Outcome Measure
CT assessment of the target stone demonstrating either (i) stone free status (zero fragments) or (ii) the presence of only stone fragments small enough to pass spontaneously (\<=4 mm) at 30 Days post procedure.
Time frame: From ELS treatment to 30 Days afterward.
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