NCT06942949 Evaluation of Enhanced Lithotripsy System (ELS) in the Treatment of Urinary Stones, A Pivotal Trial
| NCT ID | NCT06942949 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Avvio Medical |
| Condition | Kidney Calculi; Ureteral Calculi |
| Study Type | INTERVENTIONAL |
| Enrollment | 101 participants |
| Start Date | 2025-05-01 |
| Primary Completion | 2026-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 101 participants in total. It began in 2025-05-01 with a primary completion date of 2026-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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)
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06942949 clinical trial?
This trial is open to participants of all sexes, aged 21 Years or older, studying Kidney Calculi; Ureteral Calculi. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06942949 currently recruiting?
Yes, NCT06942949 is actively recruiting participants. Contact the research team at louis.marcoux@avviomed.com for enrollment information.
Where is the NCT06942949 trial being conducted?
This trial is being conducted at Phoenix, United States, Little Rock, United States, Bakersfield, United States, La Mesa, United States and 11 additional locations.
Who is sponsoring the NCT06942949 clinical trial?
NCT06942949 is sponsored by Avvio Medical. The trial plans to enroll 101 participants.
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