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Get in touch with us

Contact Applaud Medical using this form.

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Address

953 Indiana St
San Francisco, CA, 94107

Email

info@applaudmedical.com

Phone

415-761-1097

Our Clinical Study

​Acoustic Enhancer Research on Laser Lithotripsy (AEROLITH) Clinical Study

 

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ClinicalTrials.gov Identifier: NCT04563039

Applaud Medical is launching a pivotal clinical trial for our first product which is designed to improve the effectiveness and outcomes for patients receiving a Ureteroscopic Laser Lithotripsy procedure. If you are interested in participating in this study after reviewing the below, please contact our clinical team at clinicaltrial@applaudmedical.com

Trial Overview

The AEROLITH Clinical Study will evaluate the safety and effectiveness of Applaud Acoustic Enhancer when used in conjunction with conventional ureteroscopic laser lithortipsy (URS-LL) in the treatment of subjects with urinary stones. The clinical study is a prospective, multicenter, two-arm, randomized, double blinded study. A total of 196 subjects will be enrolled in this study at up to 15 investigational sites located in the U.S.
 
 
Study Type: Interventional  (Clinical Trial)
Estimated Enrollment: 196 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This study is a double blinded study in which study subjects will not be informed of their treatment allocation through the index procedure. In assessing stone fragmentation using a CT image as defined in the primary endpoint, an independent radiologist will conduct the assessment and will be blinded to the treatment allocation of each subject’s CT image.

Where to Participate

Title Address Description
Arizona Institute of Urology
4811 E Grant Rd #261, Tucson, AZ 85712, USA
University of California - Irvine (UCI) Urology, Newport Beach, CA
20350 SW Birch St, Newport Beach, CA 92660, USA
University of California - San Francisco
513 Parnassus Ave, San Francisco, CA 94143, USA
Advanced Urology, Lakewood, CO
255 Routt Street Suite 400, Lakewood, CO 80228, USA
Chesapeake Urology Associates, Baltimore, MD
7580 Buckingham Blvd Suite 110, Hanover, MD 21076, USA
Applaud Medical