Break Wave Lithotripsy and Ultrasonic Propulsion for Calculi

Phase-Based Estimates
1
Effectiveness
1
Safety
VA Puget Sound Health Care System, Seattle, WA
Calculi+3 More
Break Wave Lithotripsy and Ultrasonic Propulsion - Device
Eligibility
18+
All Sexes
Eligible conditions
Calculi

Study Summary

This study is evaluating whether a non-invasive ultrasound procedure may help treat kidney stones.

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Eligible Conditions

  • Calculi
  • Urinary Calculi
  • Urolithiasis
  • Urinary tract lithiasis (excl renal)

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Break Wave Lithotripsy and Ultrasonic Propulsion will improve 2 primary outcomes and 4 secondary outcomes in patients with Calculi. Measurement will happen over the course of Day of procedure to 4 months posts procedure.

Month 14
Safety - incidence of return healthcare visits.
Month 14
Effectiveness - Outcome from Wisconsin Stone Quality of Life questionnaire
Month 4
Effectiveness - % residual stone volume
Effectiveness - need for further stone management
Effectiveness - stone comminution into fragments 2 mm or less.
Safety - incidence of adverse events (AEs)

Trial Safety

Safety Estimate

1 of 3

Trial Design

2 Treatment Groups

Control
Treatment group

This trial requires 20 total participants across 2 different treatment groups

This trial involves 2 different treatments. Break Wave Lithotripsy And Ultrasonic Propulsion is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Treatment group
Device
This study is currently in Phase 1 where all subjects undergo the investigational study.
ControlNo treatment in the control group

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: day of procedure to 14 months post-procedure
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly day of procedure to 14 months post-procedure for reporting.

Who is running the study

Principal Investigator
J. H.
Prof. Jonathan Harper, MD
University of Washington

Closest Location

VA Puget Sound Health Care System - Seattle, WA

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 3 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
during the study were more likely to have another kidney stone during the study show original
A stone with a maximum dimension of more than 2 millimeters but less than or equal to 7 millimeters is classified as a clinical imaging determined stone. show original
People with SCI in phase 2b only will have access to the study drugs show original

Patient Q&A Section

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

Does break wave lithotripsy and ultrasonic propulsion improve quality of life for those with calculi?

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The improvement in QoL may suggest that patients with calculi would feel that their lives have been made easier as a result of the improved efficacy and shorter treatment times. This is in addition to the obvious improvement in symptoms and pain relief.

Unverified Answer

What is the average age someone gets calculi?

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A large proportion of persons living in Western Canada with bladder stones are in their 80s and 90s. Urologists need to assess the best treatment option for patients in this age range and their preferences.

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What is the primary cause of calculi?

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In men, the primary cause of benign calculus is chronic alcoholism. Data from a recent study does not support the popular myth that male calculi are caused by eating excessively high salt diets. In the absence of excessive protein intake, calculus is more likely to be caused by a low calcium diet.

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Can calculi be cured?

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There is currently no cure for calculus. Calculus often forms in the absence of serious disease, can be asymptomatic, and is typically of little concern to either patient, physician, or laboratory testing provider. However, once calculus forms in the renal tubules or the urinary bladder, calculus can affect the kidney's function. Calculus affects a person's ability to urinate, has been known to cause lower back pain, and if left untreated or not treated properly, can create serious complications. The treatment of calculus is based on the nature of the calculi and symptoms. A stone that is embedded inside the bladder will usually need to be extracted under conscious sedation or general anesthesia.

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What are the signs of calculi?

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In the hands of a trained eye, calculus is sometimes easy to spot without any radiography. However, certain factors, such as the type of calculus and the location of the calculus, can influence its appearance.

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What is calculi?

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Causes of calculi include kidney stones (calculus) that may become large enough to cause pain. When the stone becomes so big, it may start to push against one of your nerves in the abdomen (femur or leg) and cause pain.\n\nIt may also make a loud noise when it hits the surface of your body, such as your knee.\n\nLitha is a female god of the Hindu faith. She is the mother of the Hindu god Vishnu and the goddess Parvati who also is the wife of Shiva.

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What are common treatments for calculi?

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Generally speaking, common treatments for calculi may have a role in preventing recurrent disease, but the majority of published data in this journal suggest that long-term treatments may not be necessary at this stage.

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What causes calculi?

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Struvite is a common mineral contaminant in the diets of many people; it is insoluble in water; it is highly insoluble in acidic and neutral environments with a solubility and dissolution rate that can help explain the presence of struvite stones in many urine samples.\n

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How many people get calculi a year in the United States?

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Approximately 40 percent of American adults over the age of 65 yr are affected by the presence of urinary calculi. The majority of calcifications are nonvenereal in nature.

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What is break wave lithotripsy and ultrasonic propulsion?

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Ultrasound enhances the effectiveness of SWL by inducing cavitation bubbles in the stone. The cavitation bubbles lead to more destructive effects during SWL. The ultrasonic propulsion is also an effective option for SWL in patients with stones located near bifurcation of caliculi.

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What is the latest research for calculi?

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The majority of our patients will be treated by surgery and/or minimally invasive therapy. In one third of patients, a nonoperative approach will be necessary. A growing proportion of patients will require some type of parenteral (IV) therapy in order to control pain and swelling. We believe that patients will prefer these non-invasive treatments over more invasive ones. As for long-term treatment, there is no consensus or standard for the duration of the medications required, so we believe that the best option is to give the patients’ opinions, as the treatments can be the most important to the patients. Further research should be done on the effects of long-term use of medications.

Unverified Answer

Have there been other clinical trials involving break wave lithotripsy and ultrasonic propulsion?

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Data from a recent study of this trial show no conclusive difference in the recurrence of stones among the patient groups in which lithotripsy was performed with an ultrasonic lithotripter and with a probe using a technique previously reported by other research groups.

Unverified Answer
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