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Extracorporeal Shock Wave Lithotripsy

Extracorporeal Lithotripsy for Kidney Stones (SOUND Trial)

N/A

Recruiting

Research Sponsored by SonoMotion

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Target stone is indicated for shock wave lithotripsy (SWL) treatment per American Urological Association (AUA) 2016 guidelines

Target stone must be within the upper urinary tract

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 10 +/- 2 weeks post final break wave procedure

Awards & highlights

SOUND Trial Summary

This trial tests a device to safely and effectively break stones in people's urinary tracts. Participants will get follow-up care via telehealth and imaging tests.

Who is the study for?

This trial is for adults with kidney stones larger than 4mm but smaller or equal to 10mm, located in the upper urinary tract and suitable for shock wave treatment. Participants must be able to give informed consent, follow the study protocol, and attend follow-up visits. Excluded are those under 18, pregnant women, patients on anticoagulants who can't stop them temporarily, individuals with certain aneurysms or solitary kidneys, those unable to understand the consent form, anyone with untreated UTIs or urosepsis, prisoners or vulnerable groups.Check my eligibility

What is being tested?

The SOUND Pivotal Trial tests the Break Wave™ system's safety and effectiveness in breaking up kidney stones using extracorporeal lithotripsy. Patients will undergo one procedure followed by a telehealth check-in at two weeks and an imaging study around ten weeks later to assess stone fragmentation.See study design

What are the potential side effects?

Potential side effects of Break Wave extracorporeal lithotripsy may include discomfort at the site of treatment, bruising or bleeding due to shock waves passing through tissue; there could also be risks associated with sedation if used during the procedure.

SOUND Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My kidney stone is suitable for shock wave treatment according to 2016 guidelines.

Select...

My kidney stone is in the upper part of my urinary tract.

SOUND Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 10 +/- 2 weeks post final break wave procedure

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~10 +/- 2 weeks post final break wave procedure

This trial's timeline: 3 weeks for screening, Varies for treatment, and 10 +/- 2 weeks post final break wave 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

Primary Effectiveness Endpoint

Primary Safety Endpoint

Secondary outcome measures

Secondary safety endpoint

SOUND Trial Design

1Treatment groups

Experimental Treatment

Group I: Break Wave™ ProcedureExperimental Treatment1 Intervention

The subject will undergo the Break Wave procedure.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

SonoMotionLead Sponsor

1 Previous Clinical Trials

30 Total Patients Enrolled

1 Trials studying Kidney Stones

30 Patients Enrolled for Kidney Stones

Mathew D. Sorensen, M.D.Study DirectorUniversity of Washington Medicine

Frequently Asked Questions

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

How many sites are overseeing this investigation?

"10 medical centres are currently accepting participants for the study, including locations in San Francisco, Santa Clara and Chicago. To ease any burden of travelling to one's assigned clinic, it is important to select the facility closest to you when filling out your application form."

Answered by AI

Are there still opportunities available for individuals to become part of this clinical trial?

"Affirmative. The trial registry on clinicaltrials.gov reveals that the study, which was first made public on October 9th 2023, is now actively recruiting patients from 10 separate sites with a goal of 116 participants."

Answered by AI

What is the greatest number of participants in this trial?

"SonoMotion, the sponsor of this clinical trial, seeks 116 participants who meet its criteria for inclusion. Three sites have been prepared to conduct the study; University of California - San Francisco in San Francisco, Illinois and Kaiser Permanente in Santa Clara, Pennsylvania."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

SOUND Pivotal Trial - (Sonomotion stOne comminUtion resoNance ultrasounD)

2023. "SOUND Pivotal Trial - (Sonomotion stOne comminUtion resoNance ultrasounD)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05701098.

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