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

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.

Conditions

Kidney Calculi; Ureteral Calculi

Study Overview

Study Details

Study overview

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.

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

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

Condition
Kidney Calculi; Ureteral Calculi
Intervention / Treatment

-

Contacts and Locations

Sacramento

Golden State Urology, Sacramento, California, United States, 95823

Lake Barrington

Comprehensive Urologic Care, Lake Barrington, Illinois, United States, 60010

Wichita

Wichita Urology Group, Wichita, Kansas, United States, 67226

Las Vegas

Sheldon Freedman, MD, Las Vegas, Nevada, United States, 89144

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Male or Female aged \>=21 Years
  • * Provides written informed consent
  • * One urinary stone within the ureter, size \>=5 mm and \<=10 mm
  • * Stone is indicated for Shock Wavve Lithotrips Per AUA 2016 guidelines
  • * Urinary stone is present on a CT scan within past 14 days
  • * Anatomic presentations that would preclude obtaining an acoustic window for the ultrasound treatment
  • * Medical Expulsion Therapy (e.g., Flomax)
  • * Non-calcium based stones (e.g., uric acid stones)
  • * Untreated UTI
  • * Presence of abnormal skin conditions in the area to be treated
  • * Coagulation abnormality
  • * Inability to lay still for 30 minutes
  • * Pregnant
  • * Abnormal Kidney Function
  • * Any genitourinary history or procedure that has altered anatomy (e.g. urinary tract reconstruction)

Ages Eligible for Study

21 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Avvio Medical,

Study Record Dates

2025-10