Safety and Effectiveness of the Ultrasonic Propulsion of Kidney Stones

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by University of Washington
Sponsor:
Information provided by (Responsible Party):
Jonathan Harper, University of Washington
ClinicalTrials.gov Identifier:
NCT02028559
First received: January 1, 2014
Last updated: January 5, 2014
Last verified: January 2014
  Purpose

A feasibility study to test the ability to move kidney stones using a modified ultrasound system. It is the goal of our technology to move the stone fragments to a location within the kidney to improve their chances of passage, and thus reduce the occurrence of additional symptomatic events and retreatment.


Condition Intervention
Kidney Stones
Nephrolithiasis
Urolithiasis
Device: Propulse 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Safety and Effectiveness of the Ultrasonic Propulsion of Kidney Stones

Resource links provided by NLM:


Further study details as provided by University of Washington:

Primary Outcome Measures:
  • Stone movement [ Time Frame: At the time of treatment. To be evaluated with each treatment pulse - where each patient is expected to have an average of 40 pulses delivered over 1 hour ] [ Designated as safety issue: No ]
    Primary outcome measure is to move a stone a distance greater than 2 mm at the time of device application.


Secondary Outcome Measures:
  • Sensitivity [ Time Frame: At the time of treatment. To be evaluated with each treatment pulse - where each patient is expected to have an average of 40 pulses delivered over 1 hour ] [ Designated as safety issue: No ]
    Assess any patient discomfort or feeling at the time of device application. The patient will be asked directly what feeling or discomfort, if any, they experienced with the treatment pulse. The patient will be asked to fill out a pain questionnaire before and after the research study.

  • Stone direction [ Time Frame: At the time of treatment. To be evaluated with each treatment pulse - where each patient is expected to have an average of 40 pulses delivered over 1 hour ] [ Designated as safety issue: No ]
    Test ability to move the stone in a pre-determined direction with device application.

  • Stone size [ Time Frame: Established during prescreening ] [ Designated as safety issue: No ]
    Test the ability to move both large ( > 5 mm) and small ( < 5 mm) stones.

  • Device safety [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]
    Evaluation of adverse events from time of application to the 90 day follow-up.


Estimated Enrollment: 15
Study Start Date: January 2014
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment
Subjects receive treatment with study device.
Device: Propulse 1
Move kidney stones with Propulse 1 device.

Detailed Description:

Our research group has developed a new, non-invasive technology using low intensity focused ultrasound to reposition kidney stones. This is essentially a conventional diagnostic ultrasound system that is also programmed with longer ultrasounds bursts (50 ms) to impart sufficient energy to physically move a stone. These are similar to pulses that may be used in elastography or acoustic radiation force imaging. Like conventional ultrasound, the probe is placed in contact with the patient's skin to image the stone following standard ultrasound imaging procedure. The same probe is then used to focus the ultrasound and apply a burst (a sequence of pulses) of acoustic force to push the stone. Brightness mode (B-mode) imaging is interleaved with the "pushing" pulses (Push-mode) to monitor stone movement. The Push can be applied to any location and any depth within the image. The user controls the burst amplitude. To control probe surface heating, and thus patient safety, the system is programmed to control when the user is allowed to conduct the next push.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Individuals presenting to the UW urology clinic with at least one kidney stone or stone fragment that is apparent on kidney-ureter-bladder (KUB) x-ray, CT scout, or ultrasound will be eligible for this study.

Exclusion Criteria:

  • Individuals under 18 years of age
  • Individuals with non-echogenic stones
  • Individuals not following up in the UW Urology clinic for their care
  • Individuals with a coagulation abnormality or taking blood thinners or other anticoagulant
  • Individuals with mobility issues who are unable to comfortably lie for up to 30 minutes or roll from their back to their side Individuals belonging to a vulnerable group (pregnant, mentally disabled, physically disabled, prisoner, etc.)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02028559

Contacts
Contact: Barbrina Dunmire mrbean@uw.edu
Contact: Michael Bailey bailey@apl.washington.edu

Locations
United States, Washington
University of Washington Department of Urology Recruiting
Seattle, Washington, United States, 98195
Contact: Susan Ross, RN    206-543-3640    soross@uw.edu   
Principal Investigator: Jonathan Harper, MD         
Sponsors and Collaborators
University of Washington
Investigators
Principal Investigator: Jonathan Harper, MD University of Washington
  More Information

No publications provided

Responsible Party: Jonathan Harper, Assistant Professor, University of Washington
ClinicalTrials.gov Identifier: NCT02028559     History of Changes
Other Study ID Numbers: 45658-K
Study First Received: January 1, 2014
Last Updated: January 5, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Washington:
stones
kidney
stone fragments
lithotripsy

Additional relevant MeSH terms:
Calculi
Kidney Calculi
Nephrolithiasis
Urolithiasis
Pathological Conditions, Anatomical
Kidney Diseases
Urologic Diseases
Urinary Calculi

ClinicalTrials.gov processed this record on September 14, 2014