CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 196 enrolled
Drug / intervention
Ureteroscopy Laser Lithotripsy (URS-LL) with Acoustic Enhancer +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04563039
NCT04563039N/ACompleted
CompareCT.gov

Evaluation of Applaud Medical's Acoustic Enhancer With Laser Lithotripsy System in the Treatment of Urinary Stones

Avvio Medical·interventional·Posted Sep 24, 2020·Updated Apr 24, 2025

In Brief

A clinical study evaluating Ureteroscopy Laser Lithotripsy (URS-LL) with Acoustic Enhancer and Standard Ureteroscopic Laser Lithotripsy for Urinary Stones. Completed, enrolled 196 participants across 23 sites.

Detailed Summary

A pivotal study to evaluate the safety and effectiveness of Applaud Acoustic Enhancer when used in conjunction with conventional ureteroscopic laser lithotripsy (URS-LL) in the treatment of subjects with urinary stones.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsUrinary Stones
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedSep 24, 2020
Enrollment StartMay 21, 2021
Primary CompletionJul 11, 2023
Study CompletionJul 30, 2023
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 5.8 years ago

Interventions

Ureteroscopy Laser Lithotripsy (URS-LL) with Acoustic Enhancerdevice

Applaud's Acoustic Enhancer is provided in a lyophilized form. After reconstitution, it is a liquid, containing micron-scale particles that are made of a perfluoroalkane gas core with a lipid shell. The device is intended to be used with cleared/approved pulsed laser systems in fragmenting urinary stones (calculi) in the upper (superior) pole, lower (inferior) pole, and interpolar region of the kidney, pelvis of the kidney, and proximal ureter.

Standard Ureteroscopic Laser Lithotripsydevice

Standard of care Ureteroscopic Laser Lithotripsy