Our Clinical Study
Acoustic Enhancer Research on Laser Lithotripsy (AEROLITH) Clinical Study
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 |
