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Evaluation of Enhanced Lithotripsy System (ELS) in the Treatment of Urinary Stones, A Pivotal Trial
NCT06942949 · View on ClinicalTrials.gov ↗
Study 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 Studied
Interventions
- DEVICE ELS (Enhanced Lithotripsy System)
Study Locations (16)
California
- Michael G. Oefelein Clinical Trials — Bakersfield
- San Diego Clinical Trials — La Mesa
- Golden State Urology — Sacramento
Virginia
- University of Virginia — Charlottesville
- University of Virginia Community Health — Culpeper
- Urology of Virginia — Virginia Beach
New York
- University of Rochester Medical Center — Rochester
- SUNY - Upstate Medical University — Syracuse
Arizona
- Arizona State Urological Research Institute — Phoenix
Florida
- University of Miami Hospital — Miami
Georgia
- Georgia Urology — Roswell
Illinois
- Comprehensive Urologic Care — Lake Barrington
Kansas
- Wichita Urology Group — Wichita
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 101 participants |
| Start Date | 2025-05-01 |
| Est. Completion | 2026-07 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06942949
The ClinicalTrials.gov registry entry for NCT06942949 describes a study currently listed as recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 101 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Avvio Medical, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Kidney Calculi; Ureteral Calculi appearing as the primary indexed condition, and to 1 intervention — of which ELS (Enhanced Lithotripsy System) is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06942949 reports 16 study locations spanning 11 distinct geographic areas — top geographies include California, Virginia, New York. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06942949 about?
NCT06942949 is a clinical study titled "Evaluation of Enhanced Lithotripsy System (ELS) in the Treatment of Urinary Stones, A Pivotal Trial". 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, wit...
What is the current status of trial NCT06942949?
This trial is currently recruiting. It is a NA study. The enrollment target is 101 participants. The study started on 2025-05-01. Estimated completion is 2026-07.
What conditions does trial NCT06942949 study?
This clinical trial studies the following conditions: Kidney Calculi; Ureteral Calculi. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06942949?
The interventions under investigation include: ELS (Enhanced Lithotripsy System) (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06942949?
This trial is sponsored by Avvio Medical, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06942949 being conducted?
This trial has 16 study locations across Arizona, California, Florida, Georgia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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