A pivotal study to evaluate the safety and effectiveness of Applaud Acoustic Enhancer when used in conjunction with conventional ureteroscopic laser lithotripsy (URS-LL) in the treatment of subjects with urinary stones.
The AEROLITH Clinical Study will evaluate the safety and effectiveness of Applaud Acoustic Enhancer when used in conjunction with conventional ureteroscopic laser lithotripsy (URS-LL) in the treatment of subjects with urinary stones. The clinical study is a prospective, multi-center, two-arm, randomized, double blinded study. A total of 196 subjects will be enrolled in this study at up to 27 investigational sites located in the U.S.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
196
Applaud's Acoustic Enhancer is provided in a lyophilized form. After reconstitution, it is a liquid, containing micron-scale particles that are made of a perfluoroalkane gas core with a lipid shell. The device is intended to be used with cleared/approved pulsed laser systems in fragmenting urinary stones (calculi) in the upper (superior) pole, lower (inferior) pole, and interpolar region of the kidney, pelvis of the kidney, and proximal ureter.
Standard of care Ureteroscopic Laser Lithotripsy
University of Alabama
Birmingham, Alabama, United States
Number of Participants With Absence of or Have Residual Fragments Measuring Less </= to 2 mm
Study subjects who present with a complete absence of stones, or have residual fragments measuring less than or equal to 2 mm on the treatment side, as assessed by CT imaging
Time frame: At 30 days post index procedure
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Arizona Urology Specialists (Previously Arizona Institute of Urology, PLLC)
Tucson, Arizona, United States
Arkansas Urology Research Center
Little Rock, Arkansas, United States
University of California
Irvine, California, United States
University of California
San Diego, California, United States
University of California
San Francisco, California, United States
University of Florida
Gainesville, Florida, United States
University of Miami Health
Miami, Florida, United States
Northwestern University
Chicago, Illinois, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
...and 13 more locations