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

Last updated: May 6, 2025
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. 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

  • Stone is indicated for Shock Wavve Lithotrips Per AUA 2016 guidelines

  • Urinary stone is present on a CT scan within past 14 days

Exclusion

Exclusion Criteria:

  • Anatomic presentations that would preclude obtaining an acoustic window for theultrasound 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 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:
October 31, 2025

Connect with a study center

  • Golden State Urology

    Sacramento, California 95823
    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

  • Sheldon Freedman, MD

    Las Vegas, Nevada 89144
    United States

    Active - Recruiting

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