NCT04563039

Acoustic Enhancer Research on Laser Lithotripsy (AEROLITH)

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 196 (actual)
• Sponsor: Avvio Medical · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

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.

Detailed description

The AEROLITH Clinical Study will 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. The clinical study is a prospective, multi-center, two-arm, randomized, double blinded study. A total of 196 subjects will be enrolled in this study at up to 27 investigational sites located in the U.S.

Conditions

• Urinary Stones

Interventions

Type	Name	Description
DEVICE	Ureteroscopy Laser Lithotripsy (URS-LL) with Acoustic Enhancer	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.
DEVICE	Standard Ureteroscopic Laser Lithotripsy	Standard of care Ureteroscopic Laser Lithotripsy

Timeline

• Start date: 2021-05-21
• Primary completion: 2023-07-11
• Completion: 2023-07-30
• First posted: 2020-09-24
• Last updated: 2025-04-24
• Results posted: 2025-04-24

Locations

23 sites across 1 country: United States

Regulatory

• FDA-regulated device study