Ultrasound Therapy for Kidney Stones

Recruiting at 2 trial locations

Overseen By Michael Bailey, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Washington

Must not be taking: Anticoagulants

Disqualifiers: Pregnancy, Cognitive impairment, Bleeding disorders, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

20 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

If you are taking blood thinners (anticoagulants), you will need to temporarily stop them for the procedure. For other medications, the trial protocol does not specify any requirements.

What data supports the effectiveness of the treatment Break Wave Lithotripsy, Ultrasonic Propulsion for kidney stones?

Research shows that using ultrasonic propulsion can successfully move kidney stones in humans, with 94% of cases showing significant movement. Additionally, burst wave lithotripsy has been effective in breaking stones in animal models, with all tested stones being fragmented without causing harm. ^{1 2 3 4 5}

Is ultrasound therapy for kidney stones safe for humans?

Ultrasound therapy for kidney stones, including techniques like ultrasonic propulsion and burst wave lithotripsy, has been shown to be safe in humans and animal studies. No serious or unexpected side effects were reported, and any discomfort was similar to the normal experience of passing a stone. ^{1 4 6 7 8}

How is the treatment for kidney stones using Break Wave Lithotripsy and Ultrasonic Propulsion different from other treatments?

This treatment is unique because it uses noninvasive ultrasound technology to break and move kidney stones without surgery. Unlike traditional methods, it can be done in an office setting and aims to fragment and reposition stones, potentially reducing the need for more invasive procedures. ^{1 2 3 4 6}

Research Team

Jonathan Harper, MD

Principal Investigator

University of Washington

Eligibility Criteria

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.

Inclusion Criteria

I have had at least one kidney stone.

People with spinal cord injury (Phase 2b only)

You have a kidney stone that is bigger than 2 millimeters and smaller than or equal to 7 millimeters, as seen in medical images.

Exclusion Criteria

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

I understand my role in giving consent and participating.

I have a calcified aneurysm near my kidney stone.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase 1 Treatment

20 subjects undergo ultrasound treatment to demonstrate initial feasibility

Up to 30 minutes per session

1 visit (in-person)

Phase 2a Treatment

100 subjects in a two-arm randomized control trial (RCT) to test ultrasound treatment

Up to 30 minutes per session

1 visit (in-person)

Phase 2b Treatment

20 subjects with spinal cord injury undergo ultrasound treatment to demonstrate feasibility

Up to 30 minutes per session

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

14 months

Multiple visits (in-person and virtual)

Treatment Details

Interventions

• Break Wave Lithotripsy
• Ultrasonic Propulsion

Trial Overview 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.

Participant Groups

Group I: Treatment group Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

University of Washington

Lead Sponsor

Trials

1,858

Recruited

2,023,000+

Indiana University

Collaborator

Trials

1,063

Recruited

1,182,000+

VA Puget Sound Health Care System

Collaborator

Trials

67

Recruited

225,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

References

1. United States pubmed.ncbi.nlm.nih.gov

Burst wave lithotripsy and acoustic manipulation of stones. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

First Series Using Ultrasonic Propulsion and Burst Wave Lithotripsy to Treat Ureteral Stones. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Combined Burst Wave Lithotripsy and Ultrasonic Propulsion for Improved Urinary Stone Fragmentation. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Update on clinical trials of kidney stone repositioning and preclinical results of stone breaking with one system. [2020]

5. United States pubmed.ncbi.nlm.nih.gov

Recent Advances in the Science of Burst Wave Lithotripsy and Ultrasonic Propulsion. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Ultrasonic propulsion of kidney stones: preliminary results of human feasibility study. [2020]

7. United States pubmed.ncbi.nlm.nih.gov

Evaluation of Renal Stone Comminution and Injury by Burst Wave Lithotripsy in a Pig Model. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Focused Ultrasonic Propulsion of Kidney Stones. [2021]