Acoustic Enhancer Research on Laser Lithotripsy (AEROLITH)

NACompletedINTERVENTIONAL
Enrollment

196

Participants

Timeline

Start Date

May 21, 2021

Primary Completion Date

July 11, 2023

Study Completion Date

July 30, 2023

Conditions
Urinary Stones
Interventions
DEVICE

Ureteroscopy Laser Lithotripsy (URS-LL) with Acoustic Enhancer

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.

DEVICE

Standard Ureteroscopic Laser Lithotripsy

Standard of care Ureteroscopic Laser Lithotripsy

Trial Locations (23)

10019

Mount Sinai West, New York

13210

SUNY Upstate Medical University, Syracuse

17033

Penn State Milton S. Hershey Medical Center, Hershey

19004

MidLantic Urology, Bala-Cynwyd

21204

Chesapeake Urology Research Associates, Baltimore

29572

Carolina Urologic Research Center, Myrtle Beach

32610

University of Florida, Gainesville

33136

University of Miami Health, Miami

35294

University of Alabama, Birmingham

48084

Michigan Institute of Urology, Troy

60611

Northwestern University, Chicago

66160

University of Kansas Medical Center, Kansas City

67226

Wichita Urology Group, Wichita

71106

Ocshner LSU Health Shreveport - Regional Urology, Shreveport

72211

Arkansas Urology Research Center, Little Rock

77030

Baylor College of Medicine, Houston

78229

Urology San Antonio, San Antonio

85704

Arizona Urology Specialists (Previously Arizona Institute of Urology, PLLC), Tucson

92037

University of California, San Diego

92697

University of California, Irvine

94143

University of California, San Francisco

97239

Oregon Health and Sciences University, Portland

02115

Brigham and Womens Hospital, Boston

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Avvio Medical

INDUSTRY