What side effects are associated with this type of intervention?

Common treatments for kidney stones, such as extracorporeal shock wave lithotripsy (ESWL), ureteroscopy, and percutaneous nephrolithotomy, have known side effects. ESWL can cause bruising, pain, and bleeding around the kidney and nearby organs. Ureteroscopy may lead to urinary tract infections, bleeding, and ureteral injury. Percutaneous nephrolithotomy carries risks of infection, bleeding, and injury to surrounding organs. The ultrasound method being studied aims to break and reposition stones without anesthesia, potentially reducing some of these risks, but further studies are needed to confirm its safety and efficacy.

What prior FDA approvals exist?

The FDA has approved several treatments for kidney stones, including pharmacologic agents like potassium citrate to prevent stone formation and manage recurrent stones. Non-invasive techniques such as extracorporeal shock wave lithotripsy (ESWL) are also widely used and FDA-approved for breaking stones into smaller fragments that can be passed naturally. The trial studying ultrasound for breaking and repositioning stones is similar to ESWL but focuses on using ultrasound waves to facilitate stone passage without anesthesia, representing a potential advancement in non-invasive kidney stone management.

What other types of research exist?

Promising novel alternatives to ultrasound for kidney stone treatment include: <ol> <li>Shock Wave Lithotripsy (SWL): Uses high-energy shock waves to break stones into smaller fragments that can be passed naturally.</li> <li>Laser Lithotripsy: Utilizes laser energy to fragment stones during ureteroscopy, allowing for precise targeting and minimal tissue damage.</li> <li>Percutaneous Nephrolithotomy (PCNL): A minimally invasive surgical procedure where stones are removed through a small incision in the back.</li> <li>Robotic-Assisted Surgery: Enhances precision in surgical removal of stones, reducing recovery time and complications.</li> <li>Pharmacological Expulsive Therapy: Involves medications that relax the ureter, facilitating the passage of stones. These alternatives offer various benefits and should be discussed with a healthcare provider to determine the most suitable option based on individual patient needs.</li> </ol>

← Back to Search

Device

Ultrasound Therapy for Kidney Stones

N/A

Waitlist Available

Led By Jonathan Harper, MD

Research Sponsored by University of Washington

Eligibility Criteria Checklist

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

Must have

Individuals presenting with at least one kidney stone

Be older than 18 years old

Must not have

Individuals receiving anticoagulants and who are unable or not willing to temporarily cease the medication for the investigational procedure

Individuals with cognitive impairment that would limit their ability to comprehend their role in consent or participation

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day of procedure to 14 months post-procedure

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new way to help people pass kidney stones using sound waves to break and move the stones. It targets patients with kidney stones, including those with spinal cord injuries. The sound waves break the stones into smaller pieces and help move them so they can pass more easily. Focused ultrasound has been developed to successfully relocate and fragment kidney stones, showing its effectiveness in expelling small stone fragments.

Who is the study for?

This trial is for adults with kidney stones larger than 2mm but smaller or equal to 7mm. It's not for those with untreated infections, bleeding disorders, on anticoagulants they can't stop, certain aneurysms, a single kidney, urinary blockages, high comorbidity risks or cognitive impairments. Pregnant individuals and prisoners are excluded.

What is being tested?

The study tests if ultrasound can help pass kidney stones without anesthesia by breaking them up (Break Wave Lithotripsy) and repositioning them (Ultrasonic Propulsion). This multi-center research does not involve blinding participants to the treatment.

What are the potential side effects?

Potential side effects may include discomfort from the ultrasound process itself and possible complications from stone fragments passing through the urinary tract after being broken down.

Eligibility Criteria

Inclusion Criteria

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

Select...

I have had at least one kidney stone.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am on blood thinners and cannot or will not stop them for a study procedure.

Select...

I understand my role in giving consent and participating.

Select...

I have a calcified aneurysm near my kidney stone.

Select...

I currently have an infection that hasn't been treated.

Select...

I have a bleeding disorder that hasn't been treated.

Select...

I have only one kidney.

Select...

I cannot be positioned for an ultrasound scan.

Select...

I have a blockage in my urinary system that hasn't been fixed.

Select...

I am under 18 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day of procedure to 14 months post-procedure

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day of procedure to 14 months post-procedure

This trial's timeline: 3 weeks for screening, Varies for treatment, and day of procedure to 14 months post-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

Urinary Bladder Calculi (disorder)

Safety - incidence of return healthcare visits.

Secondary study objectives

Urinary Bladder Calculi (disorder)

Effectiveness - Outcome from Wisconsin Stone Quality of Life questionnaire

Effectiveness - need for further stone management

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment groupExperimental Treatment1 Intervention

This study is currently in Phase 1 where all subjects undergo the investigational study.

0 / 10Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for kidney stones include ultrasound and shock wave lithotripsy, which use high-frequency sound waves to break stones into smaller fragments, making them easier to pass. These methods are non-invasive and typically do not require anesthesia, reducing recovery time and associated risks. Pharmacologic treatments aim to alter urine composition to prevent stone formation. Understanding these mechanisms helps patients appreciate how these treatments can effectively alleviate symptoms and prevent future stone formation.

Quantitation of response to therapy in calcium urolithiasis.Metabolic risk-evaluation and prevention of recurrence in stone disease: does it make sense?New concepts in shock wave lithotripsy.