Evaluation of a new system for breaking down urinary stones
Evaluation of Enhanced Lithotripsy System (ELS) in the Treatment of Urinary Stones, A Pivotal Trial
This study is testing a new system to see if it can safely break down urinary stones into smaller pieces, making it easier for people to pass them and feel less pain.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 101 (estimated) |
| Ages | 21 Years and up |
| Sex | All |
| Sponsor | Avvio Medical Industry-sponsored |
| Locations | 16 sites (Phoenix, Arizona and 15 other locations) |
| Trial ID | NCT06942949 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and effectiveness of the Enhanced Lithotripsy System (ELS) for treating urinary stones. The ELS aims to fragment stones into smaller pieces that can be passed more easily, potentially reducing discomfort during the procedure. Eligible participants, aged 21 and older with a single ureteral stone, will undergo the ELS procedure and be assessed 30 days later using a CT scan to check for stone fragments. Additional outcomes include measuring changes in pain levels, quality of life, and the ability to return to normal activities.
Who should consider this trial
Good fit: Ideal candidates are adults aged 21 and older with a single ureteral stone between 5 mm and 10 mm in size.
Not a fit: Patients with non-calcium based stones, untreated urinary tract infections, or those with certain anatomical or medical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a less painful and more effective option for patients with urinary stones.
How similar studies have performed: Other studies have shown promise with similar lithotripsy techniques, suggesting potential for success with this novel approach.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Phoenix, Arizona and 15 other locations
- Arizona State Urological Research Institute — Phoenix, Arizona, United States (Recruiting)
- Michael G. Oefelein Clinical Trials — Bakersfield, California, United States (Recruiting)
- San Diego Clinical Trials — La Mesa, California, United States (Recruiting)
- Golden State Urology — Sacramento, California, United States (Recruiting)
- University of Miami Hospital — Miami, Florida, United States (Recruiting)
- Georgia Urology — Roswell, Georgia, United States (Recruiting)
- Comprehensive Urologic Care — Lake Barrington, Illinois, United States (Recruiting)
- Wichita Urology Group — Wichita, Kansas, United States (Recruiting)
- Minnesota Urology — Woodbury, Minnesota, United States (Recruiting)
- University of Rochester Medical Center — Rochester, New York, United States (Recruiting)
- SUNY - Upstate Medical University — Syracuse, New York, United States (Recruiting)
- Duke — Durham, North Carolina, United States (Recruiting)
- Urology San Antonio — San Antonio, Texas, United States (Recruiting)
- University of Virginia — Charlottesville, Virginia, United States (Recruiting)
- University of Virginia Community Health — Culpeper, Virginia, United States (Recruiting)
- Urology of Virginia — Virginia Beach, Virginia, United States (Recruiting)
Study contacts
- Study coordinator: Louis Marcoux
- Email: louis.marcoux@avviomed.com
- Phone: 415-887-2037
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.