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. 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:2025-10
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
  4. * Stone is indicated for Shock Wavve Lithotrips Per AUA 2016 guidelines
  5. * Urinary stone is present on a CT scan within past 14 days
  1. * Anatomic presentations that would preclude obtaining an acoustic window for the ultrasound treatment
  2. * Medical Expulsion Therapy (e.g., Flomax)
  3. * Non-calcium based stones (e.g., uric acid stones)
  4. * Untreated UTI
  5. * Presence of abnormal skin conditions in the area to be treated
  6. * Coagulation abnormality
  7. * Inability to lay still for 30 minutes
  8. * Pregnant
  9. * Abnormal Kidney Function
  10. * 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)

Golden State Urology
Sacramento, California, 95823
United States
Comprehensive Urologic Care
Lake Barrington, Illinois, 60010
United States
Wichita Urology Group
Wichita, Kansas, 67226
United States
Sheldon Freedman, MD
Las Vegas, Nevada, 89144
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 Date2025-10

Study Record Updates

Study Start Date2025-05-01
Study Completion Date2025-10

Terms related to this study

Additional Relevant MeSH Terms

  • Kidney Calculi; Ureteral Calculi