RECRUITING

Evaluation of Enhanced Lithotripsy System (ELS) in the Treatment of Urinary Stones, A Pivotal Trial

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 purpose of this study is to evaluate the safety and performance of the ELS to treat urinary stones. The ELS is intended to break urinary stones into small fragments that can pass during or after the procedure with less or no discomfort. Eligible patients are male or females, age 21 or older, with a single urinary stone in the ureter. Participants will undergo the ELS procedure and then be evaluated 30 days later for the presence or absence of urinary stone fragments on a CT scan. Subjects who still have stone present at Day 30 will be evaluated again at Day 60. Other outcome measures will be changes in pain, quality of life, and return to normal daily activities/work.

Official Title

Evaluation of Enhanced Lithotripsy System (ELS) in the Treatment of Urinary Stones, A Pivotal Trial

Quick Facts

Study Start:2025-05-01
Study Completion:2026-07
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06942949

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:21 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Male or Female aged \>=21 Years
  2. * Provides written informed consent
  3. * One urinary stone within the ureter, size \>=5 mm and \<=10 mm present on CT
  4. * Stone is indicated for Shock Wavve Lithotrips Per AUA 2026 guidelines
  5. * Stone to be treated has a maximum density of \<= 1200 HU
  1. * Anatomic presentations that would preclude obtaining an acoustic window for the ultrasound treatment
  2. * Non-calcium based stones (e.g., uric acid stones)
  3. * Untreated UTI
  4. * Presence of abnormal skin conditions in the area to be treated
  5. * Coagulation abnormality
  6. * Inability to lay still for 30 minutes
  7. * Pregnant
  8. * Abnormal Kidney Function
  9. * Any genitourinary history or procedure that has altered anatomy (e.g. urinary tract reconstruction)

Contacts and Locations

Study Contact

Louis Marcoux
CONTACT
415-887-2037
louis.marcoux@avviomed.com

Study Locations (Sites)

Arizona State Urological Research Institute
Phoenix, Arizona, 85225
United States
Michael G. Oefelein Clinical Trials
Bakersfield, California, 93301
United States
San Diego Clinical Trials
La Mesa, California, 91942
United States
Golden State Urology
Sacramento, California, 95823
United States
University of Miami Hospital
Miami, Florida, 33136
United States
Georgia Urology
Roswell, Georgia, 300076
United States
Comprehensive Urologic Care
Lake Barrington, Illinois, 60010
United States
Wichita Urology Group
Wichita, Kansas, 67226
United States
Minnesota Urology
Woodbury, Minnesota, 55125
United States
University of Rochester Medical Center
Rochester, New York, 14620
United States
SUNY - Upstate Medical University
Syracuse, New York, 13210
United States
Duke
Durham, North Carolina, 27710
United States
Urology San Antonio
San Antonio, Texas, 78229
United States
University of Virginia
Charlottesville, Virginia, 22903
United States
University of Virginia Community Health
Culpeper, Virginia, 22701
United States
Urology of Virginia
Virginia Beach, Virginia, 23462
United States

Collaborators and Investigators

Sponsor: Avvio Medical

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 Date2025-05-01
Study Completion Date2026-07

Study Record Updates

Study Start Date2025-05-01
Study Completion Date2026-07

Terms related to this study

Additional Relevant MeSH Terms

  • Kidney Calculi; Ureteral Calculi