Evaluation of Enhanced Lithotripsy System (ELS) in the Treatment of Urinary Stones, A Pivotal Trial
Avvio Medical · NCT06942949
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 21+ · All sexes
- Healthy volunteers
- Not accepted (a condition is required)
- Study type
- Interventional · Not applicable
- Target enrollment
- 101
- US sites recruiting
- 12
- Study start
- May 1, 2025
- Record last updated
- June 16, 2026
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
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.
Being studied: ELS (Enhanced Lithotripsy System)
Conditions: Kidney Calculi; Ureteral Calculi
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full criteria
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)
Recruiting US locations
Arizona State Urological Research Institute
Phoenix, AZ 85225
Site contact: Clinical Research Coordinator · 602-842-5305
San Diego Clinical Trials
La Mesa, CA 91942
Site contact: Brian Hamblen · 619-248-8517 · brianhamblen@sdclinicaltrials.com
Golden State Urology
Sacramento, CA 95823
Site contact: Clinical Research Coordinator · 925-699-7545 · ssethi@goldenstateurology.com
University of Miami Hospital
Miami, FL 33136
Site contact: Elena Cortizas · 305-243-3593 · ecortizas@med.miami.edu
Georgia Urology
Roswell, GA 300076
Site contact: Clinical Research Coordinator · 404-943-9654 · researchteam@gaurology.com
Comprehensive Urologic Care
Lake Barrington, IL 60010
Site contact: Sunny Clinical Research Coordinator · 847-382-5080 · ssian@compurocare.com
Wichita Urology Group
Wichita, KS 67226
Site contact: Clinical Research Coordinator · 316-636-6100 · tgentry@wichitaurology.com
Minnesota Urology
Woodbury, MN 55125
Site contact: Emmanuel Ogbu · 651-999-7032 · eogbu@mnurology.com
University of Rochester Medical Center
Rochester, NY 14620
Site contact: Austin Jackson · 585-602-0556 · austin.jackson@urmc.rochester.edu
SUNY - Upstate Medical University
Syracuse, NY 13210
Site contact: Diane Gould · 315-464-6105 · gouldd@upstate.edu
Urology San Antonio
San Antonio, TX 78229
Site contact: Manuel Hernandez · 210-617-4116 · manuel.hernandez@usa-clinicaltrials.com
Urology of Virginia
Virginia Beach, VA 23462
Site contact: Julia Csenar · 757-452-3463 · jcsenar@urologyofva.net
Study contacts (from the official record)
- Louis Marcoux · 415-887-2037 · louis.marcoux@avviomed.com