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

January 29, 2026 updated by: Avvio Medical
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

101

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85225
        • Recruiting
        • Arizona State Urological Research Institute
        • Principal Investigator:
          • Pratik Patel, MD
        • Contact:
          • Clinical Research Coordinator
          • Phone Number: 602-842-5305
    • California
      • Bakersfield, California, United States, 93301
        • Recruiting
        • Michael G. Oefelein Clinical Trials
        • Principal Investigator:
          • Michael Oefelein, MD
        • Contact:
      • La Mesa, California, United States, 91942
        • Recruiting
        • San Diego Clinical Trials
        • Principal Investigator:
          • Mohamed Bidair, MD
        • Contact:
      • Sacramento, California, United States, 95823
        • Recruiting
        • Golden State Urology
        • Principal Investigator:
          • Prithipal Sethi, MD
        • Contact:
    • Florida
      • Miami, Florida, United States, 33136
        • Recruiting
        • University of Miami Hospital
        • Principal Investigator:
          • Hemendra Shah, MD
        • Contact:
    • Georgia
      • Roswell, Georgia, United States, 300076
        • Recruiting
        • Georgia Urology
        • Contact:
        • Principal Investigator:
          • Adam Mellis, MD
    • Illinois
      • Lake Barrington, Illinois, United States, 60010
        • Recruiting
        • Comprehensive Urologic Care
        • Contact:
        • Principal Investigator:
          • Ning Wu, MD
    • Kansas
      • Wichita, Kansas, United States, 67226
        • Recruiting
        • Wichita Urology Group
        • Principal Investigator:
          • Timothy Richardson, MD
        • Contact:
    • Minnesota
      • Woodbury, Minnesota, United States, 55125
        • Recruiting
        • Minnesota Urology
        • Principal Investigator:
          • Aaron Milbank, MD
        • Contact:
    • New York
      • Rochester, New York, United States, 14620
        • Recruiting
        • University of Rochester Medical Center
        • Contact:
        • Principal Investigator:
          • Rajat Jain, MD
      • Syracuse, New York, United States, 13210
        • Recruiting
        • SUNY - Upstate Medical University
        • Contact:
        • Principal Investigator:
          • Scott Wiener, MD
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Recruiting
        • Duke
        • Contact:
        • Principal Investigator:
          • Robert Medairos, MD
    • Texas
      • San Antonio, Texas, United States, 78229
    • Virginia
      • Charlottesville, Virginia, United States, 22903
        • Recruiting
        • University of Virginia
        • Contact:
        • Principal Investigator:
          • Wesley Pate, MD
      • Culpeper, Virginia, United States, 22701
        • Recruiting
        • University of Virginia Community Health
        • Contact:
        • Principal Investigator:
          • Gregg Eure, MD
      • Virginia Beach, Virginia, United States, 23462
        • Recruiting
        • Urology of Virginia
        • Contact:
        • Principal Investigator:
          • James Young, MD

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.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Male or Female aged >=21 Years
  • Provides written informed consent
  • One urinary stone within the ureter, size >=5 mm and <=10 mm present on CT
  • Stone is indicated for Shock Wavve Lithotrips Per AUA 2026 guidelines
  • Stone to be treated has a maximum density of <= 1200 HU

Exclusion Criteria:

  • Anatomic presentations that would preclude obtaining an acoustic window for the ultrasound treatment
  • 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: The ELS Trial is a prospective, multi-center, single arm study.
All Subjects who qualify to participate in the ELS Trial will receive the experimental ELS procedure.
Device: ELS (Enhanced Lithotripsy System)
ELS (Enhanced Lithotripsy System) utilizes low pressure ultrasound to actuate proprietary microbubbles administered into the urine to pit and fragment urinary stones.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Primary Outcome Measure
Time Frame: From ELS treatment to 30 Days afterward.
CT assessment of the target stone demonstrating either (i) stone free status (zero fragments) or (ii) the presence of only stone fragments small enough to pass spontaneously (<=4 mm) at 30 Days post procedure.
From ELS treatment to 30 Days afterward.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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 Major Dates

Study Start (Actual)

May 1, 2025

Primary Completion (Estimated)

May 1, 2026

Study Completion (Estimated)

July 1, 2026

Study Registration Dates

First Submitted

April 17, 2025

First Submitted That Met QC Criteria

April 17, 2025

First Posted (Actual)

April 24, 2025

Study Record Updates

Last Update Posted (Actual)

February 2, 2026

Last Update Submitted That Met QC Criteria

January 29, 2026

Last Verified

April 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CIP-0002

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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