Ultrasound Therapy for Kidney Stones

Recruiting at 1 trial location

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

140 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to help people pass kidney stones using ultrasound. The treatment aims to break and move stones without anesthesia, making it less invasive. Suitable participants have at least one kidney stone between 2 mm and 7 mm, as determined by imaging tests. The study uses Break Wave Lithotripsy (a type of ultrasound therapy) and Ultrasonic Propulsion to facilitate stone passage. As an unphased trial, it offers a unique opportunity to contribute to innovative research that could lead to less invasive kidney stone treatments.

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 prior data suggests that these ultrasound techniques are safe for treating kidney stones?

Research has shown that both Break Wave Lithotripsy and Ultrasonic Propulsion are generally safe treatments for kidney stones.

For Break Wave Lithotripsy, studies have found it to be a safe and effective method that usually doesn't require anesthesia. It has been used successfully in non-surgical settings without major problems.

Ultrasonic Propulsion has also been tested in people and has shown good results. One study moved stones in 14 out of 15 participants without causing pain or side effects. Another study confirmed it could reposition stones without any negative effects.

Overall, previous studies have shown that both treatments are well-tolerated, with no major safety concerns reported. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Ultrasound Therapy for kidney stones because it offers a non-invasive alternative to traditional treatments like surgery or shock wave lithotripsy. The Break Wave Lithotripsy and Ultrasonic Propulsion methods use focused ultrasound waves to break down kidney stones and move them towards the bladder for natural expulsion. This approach promises a quicker recovery time, reduced pain, and fewer complications compared to conventional methods. Plus, the precision of ultrasound means less damage to surrounding tissues, which is a significant advantage over existing options.

What evidence suggests that ultrasound therapy is effective for kidney stones?

Research has shown that Break Wave Lithotripsy and Ultrasonic Propulsion effectively treat kidney stones. In one study, Break Wave Lithotripsy successfully broke down stones in 92% of patients. Another study found that Ultrasonic Propulsion resulted in 71% of treated stones having no pieces larger than 2 millimeters. Additionally, Ultrasonic Propulsion moved stones in 95% of cases, even when they were in difficult positions. These results suggest that these approaches can help clear small kidney stones without the need for anesthesia. ^{2 6 7 8 9}

Who Is on the Research Team?

Jonathan Harper, MD

Principal Investigator

University of Washington

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: Phase I: Feasibility Treatment group Experimental Treatment 1 Intervention

Initial phase of the trial to demonstrate feasibility. All subjects undergo the investigational intervention.

Group II: Phase 2b: Spinal Cord Injury Feasibility Study Experimental Treatment 1 Intervention

Feasbility study of the investigational intervention in subjects with spinal cord injury.

Group III: Phase 2a: Treatment Group of a randomized control trial Experimental Treatment 1 Intervention

RCT phase of the trial to demonstrate superiority. All subjects undergo the investigational intervention.

Group IV: Phase 2a: Control group of a randomized control trial Active Control 1 Intervention

RCT phase of the trial to demonstrate superiority. All subjects are the concurrent Control to the Phase 2a Treatment group. Subjects receive no intervention.

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+

Citations

1.

auajournals.org

auajournals.org/doi/10.1097/JU.0000000000004091

Break Wave Lithotripsy for Urolithiasis: Results of the First- ...

After determining optimal therapy settings, 36 patients were treated and the effectiveness improved exhibiting fragmentation in 92% (33/36), ...

2.

urologytimes.com

urologytimes.com/view/bwl-plus-ultrasonic-propulsion-shows-safety-efficacy-for-small-renal-stones

BWL plus ultrasonic propulsion shows safety, efficacy for ...

Data showed that the primary effectiveness outcome of no fragment greater than 2 mm was achieved in 22 of 31 stones (71%) treated. Additionally, ...

3.

auajournals.org

auajournals.org/doi/10.1097/JU.0000000000004533

Facilitated Clearance of Small, Asymptomatic Renal ...

BWL and ultrasonic propulsion were successful in fragmenting and clearing small kidney stones, in awake participants in a clinic setting.

4.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC6798799/

Quantitative Assessment of Effectiveness of Ultrasonic ...

Conclusions: Ultrasonic propulsion was shown to be safe, and it effectively repositioned stones in 95% of kidneys despite positioning and access restrictions ...

5.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10117400/

Recent Advances in the Science of Burst Wave Lithotripsy and ...

Kidney stone fragmentation and repositioning by BWL and ultrasonic propulsion have shown promising results in preclinical and clinical trials. Based on the ...

6.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/39254129/

Break Wave Lithotripsy for Urolithiasis: Results of the First- ...

BWL offered safe and effective noninvasive stone therapy requiring little to no anesthesia and was carried out successfully in nonoperative environments.

7.

urologytimes.com

urologytimes.com/view/data-suggest-break-wave-lithotripsy-is-safe-effective-for-urolithiasis

Data suggest Break Wave lithotripsy is safe, effective for ...

Break Wave Lithotripsy appears to be safe and effective in the treatment of patients with urolithiasis, according to data from a first-in-human, prospective, ...

8.

clinicaltrials.gov

clinicaltrials.gov/study/NCT03811171

Study Details | NCT03811171 | Break Wave(TM) ...

This is a prospective, open-label, multi-center, single-arm (non-randomized) study to assess the safety and effectiveness of breaking stones in the upper ...

9.

tau.amegroups.org

tau.amegroups.org/article/view/63248/html

Outcomes of extracorporeal shock wave lithotripsy for ureteral ...

Although ESWL is a very safe procedure, it rarely causes life-threatening complications, such as renal hematoma or surrounding organ injuries. Therefore, it is ...