Ultrasound to Facilitate Stone Passage

March 29, 2023 updated by: Jonathan Harper, MD, University of Washington

Ultrasound Technology to Fragment and Reposition Urinary Stones

This is a prospective, open-label, multi-center study to test the clinical feasibility of facilitating stone passage by the combination of breaking and repositioning stones with ultrasound, without the need for anesthesia.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a prospective, open-label, multi-center study to test the clinical feasibility of facilitating stone passage by the combination of breaking and repositioning stones with ultrasound, without the need for anesthesia.

Subjects will be included across three phases:

Phase 1: 20 subjects to demonstrate initial feasibility Phase 2a: 100 subjects for a two-arm (50:50) randomized control trial (RCT) Phase 2b: 20 subjects to demonstrate feasibility in individuals with spinal cord injury (SCI)

This study is currently in Phase 1. Phase 2a and 2b are intended to be conducted in parallel and will not be initiated until after review of the Phase 1 results and approval to proceed to Phase 2 by the FDA.

Up to 3 distinct targets may be treated per subject. The maximum total dose exposure is 30 minutes for one session. Subjects may return after at least 21 days and after all AEs have resolved for an additional session on the same side. Subjects may return after imaging follow-up for inclusion of their contralateral side.

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Michael Bailey, PhD
  • Phone Number: 206-619-2035
  • Email: mbailey@uw.edu

Study Contact Backup

Study Locations

  • United States
    • Indiana
      • Carmel, Indiana, United States, 46032
        • Indiana University Health - North Hospital
        • Principal Investigator:
          • James Lingeman, MD
        • Contact:
    • Washington
      • Seattle, Washington, United States, 98195
        • University of Washington
        • Contact:
          • Michael Bailey, PhD
          • Phone Number: 206-619-2035
          • Email: mbailey@uw.edu
        • Contact:
        • Principal Investigator:
          • Jonathan Harper, MD
      • Seattle, Washington, United States, 98108
        • VA Puget Sound Health Care System
        • Contact:
        • Principal Investigator:
          • Claire Yang, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Individuals presenting with at least one kidney stone
  • Stone with maximum dimension > 2 mm and ≤ 7 mm as determined by clinical imaging
  • Individuals with SCI - (Phase 2b only)

Exclusion Criteria:

  • Individuals under 18 years of age
  • Individuals who are pregnant or who are trying to get pregnant
  • Prisoners
  • with cognitive impairment that would limit their ability to comprehend their role in consent or participation.
  • Individuals who are unable to read or understand English
  • Individuals who are unable or unwilling to participate in follow up activities
  • Individuals who cannot be positioned for ultrasound imaging
  • Individuals with uncorrected bleeding disorders or coagulopathies
  • Individuals receiving anticoagulants and who are unable or not willing to temporarily cease the medication for the investigational procedure
  • Individuals with a calcified abdominal aortic aneurysm or calcified renal artery aneurysm ipsilateral to the renal stone targeted by the investigational procedure
  • Individuals with a solitary kidney
  • Individuals with an uncorrected urinary tract obstruction
  • Individuals with an untreated infection
  • Individuals with a comorbidity risk which, at the discretion of the physician, would make the patient a poor candidate for the investigational procedure
  • Individuals who have received two previous investigational procedures for the same stone target
  • Individuals who have undergone the investigational procedure within the last 21 days or still have unresolved AEs from a previous investigational procedure.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment group
This study is currently in Phase 1 where all subjects undergo the investigational study.
Device: Break Wave Lithotripsy and Ultrasonic Propulsion
Novel ultrasound technologies to facilitate passage of stones.This includes Burst Wave Lithotripsy (BWL), a technology to noninvasively fragment urinary calculi within the kidney and ureter, and ultrasonic propulsion, a technology to non-invasively reposition stones within the kidney and ureter. BWL uses short multi-cycle bursts of low amplitude ultrasound to induce stone fracture. This is in contrast to traditional extracorporeal shock wave lithotripsy (SWL), which employs a brief single compression/tensile cycle of high amplitude (shock) waves to achieve stone fracture. Ultrasonic propulsion uses long multi-cycle bursts of low amplitude ultrasound to move stones within the collecting system.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety - incidence of return healthcare visits.
Time Frame: Day of procedure to 14 months post-procedure
Incidence of return health care visits associated with the device or procedure.
Day of procedure to 14 months post-procedure
Effectiveness - stone comminution into fragments 2 mm or less.
Time Frame: Day of procedure to 4 months posts procedure
Number of cases where the largest dimension of any residual stone in the study kidney is less than or equal to 2 mm.
Day of procedure to 4 months posts procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety - incidence of adverse events (AEs)
Time Frame: Day of procedure to 4 months posts procedure
The incidence of all adverse events (AEs) associated with the device or procedure
Day of procedure to 4 months posts procedure
Effectiveness - % residual stone volume
Time Frame: Day of procedure to 4 months posts procedure
Residual stone volume relative to the initial stone volume
Day of procedure to 4 months posts procedure
Effectiveness - need for further stone management
Time Frame: Day of procedure to 4 months posts procedure
Incidence of new healthcare visits for further stone management
Day of procedure to 4 months posts procedure
Effectiveness - Outcome from Wisconsin Stone Quality of Life questionnaire
Time Frame: Day of procedure to 14 months posts procedure
Quality of life, evaluated by the comparison of Wisconsin Stone Quality of Life (WISQOL) questionnaire scores before and after the investigational procedure. The questionnaire consists of a series of questions to evaluate the symptomatic and functional impact of the stones on a scale of 1 to 5, where a lower score indicates a greater impact. https://urology.wisc.edu/research/wisqol/.
Day of procedure to 14 months posts procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Washington

Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Indiana University
VA Puget Sound Health Care System

Investigators

  • Principal Investigator: Jonathan Harper, MD, University of Washington

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

July 1, 2023

Primary Completion (Anticipated)

May 31, 2028

Study Completion (Anticipated)

October 31, 2028

Study Registration Dates

First Submitted

March 3, 2021

First Submitted That Met QC Criteria

March 10, 2021

First Posted (Actual)

March 15, 2021

Study Record Updates

Last Update Posted (Actual)

March 31, 2023

Last Update Submitted That Met QC Criteria

March 29, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00011687
  • 5P01DK043881-26 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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