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New treatment option for Kidney Calculi; Ureteral Calculi
Official title Evaluation of Enhanced Lithotripsy System (ELS) in the Treatment of Urinary Stones, A Pivotal Trial
ClinicalTrials.gov ID: NCT06942949
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 21 and older
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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
- 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)
The study team makes the final eligibility decision.
Where it's taking place
- Phoenix, Arizona, United States
- Little Rock, Arkansas, United States
- Bakersfield, California, United States
- La Mesa, California, United States
- Sacramento, California, United States
- Miami, Florida, United States
- Roswell, Georgia, United States
- Lake Barrington, Illinois, United States
- Wichita, Kansas, United States
- Woodbury, Minnesota, United States
- Lincoln, Nebraska, United States
- Reno, Nevada, United States
- Rochester, New York, United States
- Syracuse, New York, United States
- Durham, North Carolina, United States
- Sioux City, South Dakota, United States
- San Antonio, Texas, United States
- Charlottesville, Virginia, United States
- Culpeper, Virginia, United States
- Virginia Beach, Virginia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 21 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Phoenix, Arizona, United States; Little Rock, Arkansas, United States; Bakersfield, California, United States; La Mesa, California, United States; Sacramento, California, United States; Miami, Florida, United States and 14 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.