← Back to Search

Procedure

Ureteroscopy Laser Lithotripsy (URS-LL) with Acoustic Enhancer for Kidney Stones (AEROLITH Trial)

N/A
Waitlist Available
Research Sponsored by Applaud Medical, Inc.
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

AEROLITH Trial 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.Check my eligibility
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.See study design
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.

AEROLITH Trial 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

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

AEROLITH 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

Find a Location

Who is running the clinical trial?

Applaud Medical, Inc.Lead Sponsor
1 Previous Clinical Trials
3 Total Patients Enrolled
Tessa YamutStudy DirectorApplaud Medical, Inc.
2 Previous Clinical Trials
323 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there numerous medical centers testing this protocol in North America?

"This clinical trial is taking place in multiple sites, including Chesapeake Urology Research Associates 2 (Towson, MD), Chesapeake Urology Associates (Baltimore, California) and University of California San Francisco (Florida). In addition to these three locations, there are an additional 28 participating medical centres."

Answered by AI

Can I enroll in this medical investigation?

"This research requires 196 individuals aged between 18 to 75 that possess a single or dual kidney. In addition, the following criteria must be met: gender (male/female), signed consent, 6mm+ stone proximal to iliac vessels on one side with maximum cumulative diameter of 20mm as determined by CT scan within 60 days pre-enrollment; absence of UTI confirmed through urinalysis and ability for participant to enter trial with stent in place if applicable."

Answered by AI

Are there any vacancies to participate in this experiment?

"Affirmative. According to records on clinicaltrials.gov, this research initiative is currently recruiting subjects; it was initially posted in May of 2021 and most recently updated in November 2022. 196 people are being sought from 28 distinct sites for the study's purposes."

Answered by AI

Are adolescents eligible to participate in this medical experiment?

"Adults aged 18 to 75 are the primary focus of this medical trial, although there is an auxiliary investigation for minors and a separate one targeting seniors over 65."

Answered by AI

What is the sample size for this experimental research?

"Indeed, clinicaltrials.gov confirms that this medical study is currently enrolling patients; the trial was first announced on May 21st 2021 and has been recently updated on November 11th 2022. A total of 196 participants need to be recruited from 28 distinct sites."

Answered by AI

Who else is applying?

What state do they live in?
Maryland
California
How old are they?
18 - 65
65+
What site did they apply to?
University of California
Chesapeake Urology Associates
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Acoustic Enhancer Research on Laser Lithotripsy (AEROLITH)
2021. "Acoustic Enhancer Research on Laser Lithotripsy (AEROLITH)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04563039.
All > Vestibular Schwannoma
~51 spots leftby Apr 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top