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Procedure

Laser Lithotripsy for Kidney Stones (AEROLITH Trial)

N/A
Waitlist Available
Research Sponsored by Avvio Medical
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through 90 days post index procedure
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new device to help break up kidney stones during a common procedure.

Who is the study for?
Adults aged 18-75 with kidney stones visible on a CT scan, who don't have an infection or certain medical conditions like cystinuria, recent surgeries, or involvement in other trials. Participants can have stents and bilateral stones but only one side will be treated.
What is being tested?
The study is testing the Applaud Acoustic Enhancer's safety and effectiveness alongside standard laser treatment for breaking down kidney stones. It compares outcomes of those using the enhancer with those receiving conventional treatment.
What are the potential side effects?
Potential side effects may include discomfort at the site of treatment, bleeding, possible infections from the procedure, reactions to anesthesia used during lithotripsy, and stone fragments causing blockage.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through 90 days post index procedure
This trial's timeline: 3 weeks for screening, Varies for treatment, and through 90 days post index procedure for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Efficacy: Absence of or have residual fragments measuring less </= to 2 mm
Secondary study objectives
Safety: Total Radiant Energy Used in the Treatment
Other study objectives
Efficacy: Proportion of study subjects undergoing additional interventional stone treatment
Safety: Measurement of Lasering Time During Treatment
Safety: Proportion of Adverse Events

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Ureteroscopic Laser Lithotripsy with Acoustic EnhancerExperimental Treatment1 Intervention
Ureteroscopic Laser Lithotripsy with Acoustic Enhancer
Group II: Standard Ureteroscopic Laser LithotripsyActive Control1 Intervention
Standard Ureteroscopic Laser Lithotripsy

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Who is running the clinical trial?

Avvio MedicalLead Sponsor
2 Previous Clinical Trials
16 Total Patients Enrolled
Applaud Medical, Inc.Lead Sponsor
2 Previous Clinical Trials
16 Total Patients Enrolled
Tessa YamutStudy DirectorAvvio Medical
2 Previous Clinical Trials
323 Total Patients Enrolled
~43 spots leftby Dec 2025
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