Clinical Studies

Current Study

Enhanced Lithotripsy System (ELS) Clinical Trial

Avvio Medical is conducting a prospective, multi-center, single-arm clinical trial to evaluate the safety and efficacy of the Enhanced Lithotripsy System (ELS) for the fragmentation of urinary stones in the ureter (proximal, middle, and distal). The ELS Trial will enroll up to 101 patients across up to 20 investigational sites in the United States, ensuring a diverse patient population.

This study represents a significant step in advancing stone treatment technology, offering a potential new solution for patients suffering from ureteral stones.

ClinicalTrials.gov ID: NCT06942949

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Previous Studies

First-in-Human Study

Our first-in-human, multicenter clinical trial conducted in Australia, demonstrated that Avvio Medical’s minimally invasive, microbubble- assisted acoustic lithotripsy delivers strong efficacy with a superior safety profile. The study was comprised of 33 patients  with average stone size >6mm (range 5-10mm) and a balanced mix of distal and proximal ureteral stones. At 30 days, patients were evaluated with CT and KUB imaging for the presence of ureteral stones.

With up to 78% stone-free rates (SFR) and low adverse event rates, Avvio is positioned to transform kidney stone treatment with a safer, simpler, and more scalable alternative.

Acoustic Enhancer Research on Laser Lithotripsy (AEROLITH)

The objective of the AEROLITH Study was to evaluated the safety and effectiveness of Avvio 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 lithotripsy (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.

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Interested in participating in future clinical studies Avvio Medical is planning?

If you are interested in participating in future clinical studies Avvio Medical may implement, please contact us.

Note: We are only accepting interest from potential investigators/sites located in the U.S.

*Data on file
CAUTION – Investigational device. Limited by Federal (or United States) law to investigational use. Avvio Medical, Inc. does not currently offer medical devices for sale or distribution and the company’s technology has not received market clearance status by the U.S. FDA or any other country’s regulatory authority.
MKT-006 Revision O, April 2025.