MedTrace Logo

Acoustic Enhancer Research on Laser Lithotripsy (AEROLITH)

NCT04563039 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 196

Last updated 2025-04-24

Study results available
· View outcomes & findings →

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.

Conditions

  • Urinary Stones

Interventions

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

Sponsors & Collaborators

  • Avvio Medical

    lead INDUSTRY

Principal Investigators

  • Tessa Yamut · Avvio Medical

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-05-21
Primary Completion
2023-07-11
Completion
2023-07-30
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04563039 on ClinicalTrials.gov