Our Clinical Study
Acoustic Enhancer Research on Laser Lithotripsy (AEROLITH) Clinical Study
ClinicalTrials.gov Identifier: NCT04563039
Applaud Medical has completed enrollment of the pivotal clinical trial for the company’s first product which is designed to improve the effectiveness and outcomes for patients receiving a Ureteroscopic Laser Lithotripsy procedure.
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|
|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.|