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.
|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.|