ACTIVE_NOT_RECRUITING

SOUND Pivotal Trial - (Sonomotion stOne comminUtion resoNance ultrasounD)

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Conditions

Kidney StoneUrolithiasisNephrolithiasisRenal CalculiKidney CalculiNephrolithUrinary CalculiUltrasound therapyNon-invasiveExtracorporeal

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The goal of this clinical trial is to test the Break Wave™ system in patients with upper urinary tract stones. The main question it aims to answer is whether the device is safe and effective in fragmenting (breaking) stones. Participants will a) undergo the Break Wave™ procedure, b) have a telehealth visit at 2 weeks, and c) return for an imaging study at approximately 10 weeks post-procedure.

Official Title

Pivotal Study of the SonoMotion Break Wave™ (Trade Mark) System for the Comminution of Urinary Tract Stones

Quick Facts

Study Start:2023-10-09
Study Completion:2026-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05701098

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Subjects presenting with at least one stone apparent on radiographic imaging.
  2. 2. Target stone must be within the upper urinary tract.
  3. 3. Target stone is indicated for shock wave lithotripsy (SWL) treatment per American Urological Association (AUA) 2016 guidelines.
  4. 4. Target stone size is \> 4 mm and ≤ 10 mm.
  5. 5. Subject is willing and able to provide informed consent and comply with the study protocol required follow up visits.
  6. 6. Target stone can be individually visualized from other stones.
  1. 1. Subject has an acute untreated urinary tract infection or urosepsis.
  2. 2. Subject has an uncorrected bleeding disorder or coagulation abnormality.
  3. 3. Subject is confirmed to be or suspected to be pregnant.
  4. 4. Subject has a urinary tract obstruction distal to the stone.
  5. 5. Subject is receiving anticoagulants and is unable or not willing to cease the medication for the Break Wave procedure
  6. 6. Subject has stones that are not echogenically visible with ultrasound.
  7. 7. Subject belongs to a vulnerable group (prisoner, etc.).
  8. 8. Patients unwilling to comply with the follow-up protocol, including post-procedure radiographic imaging.
  9. 9. Subject is under 18 years of age.
  10. 10. Subject's anatomy limits ability to focus on or deliver Break Wave to the target stone (e.g. viable acoustic window).
  11. 11. Subject has a calcified abdominal aortic aneurysm or calcified renal artery aneurysms.
  12. 12. Subject has a solitary kidney.
  13. 13. Subject has a comorbidity risk(s) which, at the discretion of the physician, would make the subject a poor candidate for the Break Wave procedure, such as anatomical anomalies that may not be conducive to adequate stone fragment passage.
  14. 14. Subject is unable to read or comprehend the consent form.

Contacts and Locations

Study Locations (Sites)

University of California- San Diego
San Diego, California, 92037
United States
University of California - San Francisco
San Francisco, California, 94143
United States
Kaiser Permanente
Santa Clara, California, 95051
United States
Northwestern Medicine
Chicago, Illinois, 60611
United States
Lehigh Valley Health Network
Allentown, Pennsylvania, 18103
United States
Vanderbilt University
Nashville, Tennessee, 37232
United States
University of Washington
Seattle, Washington, 98195
United States

Collaborators and Investigators

Sponsor: SonoMotion

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 Registration Dates

Study Start Date2023-10-09
Study Completion Date2026-01

Study Record Updates

Study Start Date2023-10-09
Study Completion Date2026-01

Terms related to this study

Keywords Provided by Researchers

  • Kidney Stone
  • Urolithiasis
  • Nephrolithiasis
  • Renal Calculi
  • Kidney Calculi
  • Nephrolith
  • Urinary Calculi
  • Ultrasound therapy
  • Non-invasive
  • Extracorporeal

Additional Relevant MeSH Terms

  • Kidney Stone
  • Urolithiasis
  • Nephrolithiasis
  • Renal Calculi
  • Kidney Calculi
  • Nephrolith
  • Urinary Calculi