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

Last updated: June 15, 2026
Sponsor: Avvio Medical
Overall Status: Active - Recruiting

Phase

N/A

Condition

Kidney Stones

Treatment

ELS (Enhanced Lithotripsy System)

Clinical Study ID

NCT06942949
CIP-0002
  • Ages > 21
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  • Anatomic presentations that would preclude obtaining an acoustic window for theultrasound 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 tractreconstruction)

Study Design

Total Participants: 101
Treatment Group(s): 1
Primary Treatment: ELS (Enhanced Lithotripsy System)
Phase:
Study Start date:
May 01, 2025
Estimated Completion Date:
September 30, 2026

Connect with a study center

  • Arizona State Urological Research Institute

    Phoenix, Arizona 85225
    United States

    Active - Recruiting

  • Arkansas Urology Research Center

    Little Rock, Arkansas 72211
    United States

    Site Not Available

  • Michael G. Oefelein Clinical Trials

    Bakersfield, California 93301
    United States

    Site Not Available

  • San Diego Clinical Trials

    La Mesa, California 91942
    United States

    Active - Recruiting

  • Golden State Urology

    Sacramento, California 95823
    United States

    Active - Recruiting

  • University of Miami Hospital

    Miami, Florida 33136
    United States

    Active - Recruiting

  • Georgia Urology

    Roswell, Georgia 300076
    United States

    Active - Recruiting

  • Comprehensive Urologic Care

    Lake Barrington, Illinois 60010
    United States

    Active - Recruiting

  • Wichita Urology Group

    Wichita, Kansas 67226
    United States

    Active - Recruiting

  • Minnesota Urology

    Woodbury, Minnesota 55125
    United States

    Active - Recruiting

  • Nebraska Urology

    Lincoln, Nebraska 68516
    United States

    Site Not Available

  • Urology Nevada

    Reno, Nevada 89511
    United States

    Site Not Available

  • University of Rochester Medical Center

    Rochester, New York 14620
    United States

    Active - Recruiting

  • SUNY - Upstate Medical University

    Syracuse, New York 13210
    United States

    Active - Recruiting

  • Duke

    Durham, North Carolina 27710
    United States

    Site Not Available

  • Urology Specialists Clinic

    Sioux City, South Dakota 57108
    United States

    Site Not Available

  • Urology San Antonio

    San Antonio, Texas 78229
    United States

    Active - Recruiting

  • University of Virginia

    Charlottesville, Virginia 22903
    United States

    Site Not Available

  • University of Virginia Community Health

    Culpeper, Virginia 22701
    United States

    Site Not Available

  • Urology of Virginia

    Virginia Beach, Virginia 23462
    United States

    Active - Recruiting

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