Recruiting

Enhanced Lithotripsy System

Sponsor:

Avvio Medical

Code:

NCT06942949

Conditions

Kidney Calculi; Ureteral Calculi

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

Interventions

ELS (Enhanced Lithotripsy System)

Study Details

Brief 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.

Conditions

Kidney Calculi; Ureteral Calculi

Study ID

NCT06942949

Start date

May 1, 2025

Status verified date

Jul, 2025

Completion date

Sep, 2026

Anticipated

Primary completion date

Aug, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

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 Design

Enrollment

101 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

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.

Primary outcome measure

  • Primary Outcome Measure [ Time Frame: From ELS treatment to 30 Days afterward. ]

Central Contacts and Locations

Central contacts

Louis Marcoux

415-887-2037louis.marcoux@avviomed.com

Locations

Arizona State Urological Research Institute

Recruiting

Phoenix, Arizona, United States, 85225

Contacts

Clinical Research Coordinator

602-842-5305

Principal Investigator:

Pratik Patel, MD

San Diego Clinical Trials

Recruiting

La Mesa, California, United States, 91942

Contacts

Brian Hamblen

619-248-8517brianhamblen@sdclinicaltrials.com

Principal Investigator:

Mohamed Bidair, MD

Golden State Urology

Recruiting

Sacramento, California, United States, 95823

Contacts

Clinical Research Coordinator

925-699-7545ssethi@goldenstateurology.com

Principal Investigator:

Prithipal Sethi, MD

University of Miami Hospital

Recruiting

Miami, Florida, United States, 33136

Contacts

Elena Cortizas

305-243-3593ecortizas@med.miami.edu

Principal Investigator:

Hemendra Shah, MD

Georgia Urology

Recruiting

Roswell, Georgia, United States, 300076

Contacts

Clinical Research Coordinator

404-943-9654researchteam@gaurology.com

Principal Investigator:

Adam Mellis, MD

Comprehensive Urologic Care

Recruiting

Lake Barrington, Illinois, United States, 60010

Contacts

Sunny Clinical Research Coordinator

847-382-5080ssian@compurocare.com

Principal Investigator:

Ning Wu, MD

Wichita Urology Group

Recruiting

Wichita, Kansas, United States, 67226

Contacts

Clinical Research Coordinator

316-636-6100tgentry@wichitaurology.com

Principal Investigator:

Timothy Richardson, MD

Minnesota Urology

Recruiting

Woodbury, Minnesota, United States, 55125

Contacts

Emmanuel Ogbu

651-999-7032eogbu@mnurology.com

Principal Investigator:

Aaron Milbank, MD

University of Rochester Medical Center

Recruiting

Rochester, New York, United States, 14620

Contacts

Austin Jackson

585-602-0556austin.jackson@urmc.rochester.edu

Principal Investigator:

Rajat Jain, MD

SUNY - Upstate Medical University

Recruiting

Syracuse, New York, United States, 13210

Contacts

Diane Gould

315-464-6105gouldd@upstate.edu

Principal Investigator:

Scott Wiener, MD

Urology San Antonio

Recruiting

San Antonio, Texas, United States, 78229

Contacts

Manuel Hernandez

210-617-4116manuel.hernandez@usa-clinicaltrials.com

Principal Investigator:

Matthias Hofer, MD

Urology of Virginia

Recruiting

Virginia Beach, Virginia, United States, 23462

Contacts

Julia Csenar

757-452-3463jcsenar@urologyofva.net

Principal Investigator:

James Young, MD

More Information

Sponsor

Avvio Medical

Last update posted

Jun 16, 2026

Last verified

Jul, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Avvio Medical on 2026-06-16.