Clinical Studies
Acoustic Enhancer Research on Laser Lithotripsy (AEROLITH)
ClinicalTrials.gov Identifier: NCT04563039
The objective of the AEROLITH Study was to evaluated the safety and effectiveness of Applaud Medical’s Acoustic Enhancer technology in subjects with urinary stones.
Methodology
- Prospective, multicenter, two-arm, randomized, double blinded study.
- Acoustic Enhancer microbubbles used in conjunction with conventional ureteroscopic laser lithortipsy (URS-LL) versus URS-LL alone.
- The study enrolled 196 subjects at 23 investigational sites located in the U.S.
- Primary endpoint: Complete absence of stones, or have residual fragments measuring <2 mm, as assessed by CT imaging.
Results
- Data currently being analyzed.
