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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, Tucson, AZ
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, CA
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
University of Alabama, Birmingham, AL
1720 2nd Ave S, Birmingham, AL 35294, USA
University of California, San Diego, CA
South Wing, 200 W Arbor Dr, San Diego, CA 92103, USA
University of Florida, Gainesville, FL
1600 SW Archer Rd, Gainesville, FL 32608, USA
Northwestern University, Chicago, IL
675 N St Clair St Suite 20-150, Chicago, IL 60611, USA
Brigham and Womens Hospital, Boston, MA
45 Francis St, Boston, MA 02115, USA
Mount Sinai West, New York, NY
1070 Park Ave, New York, NY 10128, USA
SUNY Upstate Medical University, Syracuse, NY
4900 Broad Rd #4v, Syracuse, NY 13215, USA
Ohio State University, Columbus, OH
456 W 10th Ave, Columbus, OH 43210, USA
University of Pittsburgh Medical Center, Pittsburgh, PA
1350 Locust St Suite G100A, Pittsburgh, PA 15219, USA
Brigham & Women's Hospital, Boston, MA
75 Francis St, Boston, MA 02115, USA
Baylor College of Medicine, Houston, TX
7200 Cambridge St #10b, Houston, TX 77030, USA

Study Sites

Click on the + symbol next to the site name for more information.

University of Alabama, Birmingham, Alabama

Status: Recruiting

Contact: Kyle Wood, MD  kylewood@uabmc.edu

Arizona Institute of Urology, PLLC, Tucson, Arizona

Status: Recruiting

Contact: Jay Page, MD   jpage@aiurology.com    

University of California, Irvine, California

Status: Recruiting

Contact: Roshan Patel, MD   roshanmp@hs.uci.edu    

University of California, San Diego, California

Status: Recruiting

Contact: Roger Sur, MD   rlsur@health.ucsd.edu    

University of California, San Francisco, California

Status: Recruiting

Contact: Thomas Chi, MD   Tom.chi@ucsf.edu  

Advanced Urology, PLLC, Lakewood, Colorado

Status: Recruiting

Contact: TDavid J. Cahn, MD dcahn@coloradouro.com

University of Florida, Gainesville, Florida

Status: Recruiting

Contact: Vincent Bird, MD   Vincent.bird@urology.ufl.edu

Northwestern University, Chicago, Illinois

Status: Not Yet Recruiting

Contact: Amy Krambeck, MD   amy.krambeck@nm.org

Chesapeake Urology Associates, Baltimore, Maryland

Status: Recruiting

Contact: Julio Davalos, MD    jdavalos@chesuro.com

Brigham and Womens Hospital, Boston, Massachusetts

Status: Recruiting

Contact: Daniel Wollin, MD    dwollin@partners.org

SUNY Upstate Medical University, Syracuse, New York

Status: Recruiting

Contact: Scott Weiner, MD   WienerSc@upstate.edu

Ohio State University, Columbus, Ohio

Status: Recruiting

Contact: Bodo Knudsen, MD bodo.knudsen@osumc.edu 

University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania

Status: Recruiting

Contact: Michelle Semins, MD  seminsmj@upmc.edu

Brigham & Women's Hospital, Boston, Massachusetts

Status: Recruiting

Contact: Daniel Wollin, MD   dwollin@partners.org

Baylor College of Medicine, Houston, Texas

Status: Recruiting

Contact: Wesley Mayer, MD   wesley.mayer@bcm.edu

Applaud Medical