Our Clinical Study

Acoustic Enhancer Research on Laser Lithotripsy (AEROLITH) Clinical Study

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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.

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.