Kidney Calculi; Ureteral CalculiELSNCT06942949
Evaluation of Enhanced Lithotripsy System (ELS) in the Treatment of Urinary Stones, A Pivotal Trial
A study testing ELS (Enhanced Lithotripsy System) in people with Kidney Calculi; Ureteral Calculi, run by Avvio Medical at 20 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Kidney Calculi; Ureteral Calculi
- What is being tested?
- ELS (Enhanced Lithotripsy System)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 20 sitesUnited States
- Study dates
- 1 May 2025to Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Pregnant
- Abnormal Kidney Function
- Any genitourinary history or procedure that has altered anatomy (e.g. urinary tract reconstruction)
Trial locations and contacts
20 sites in 1 country. Contact the study team or a site near you to ask about taking part.
20 sites in 1 country
United States20 sites, 16 recruiting
- Active, not recruiting
Michael G. Oefelein Clinical Trials
Bakersfield, California, 93301
- Withdrawn
University of Virginia
Charlottesville, Virginia, 22903
- Active, not recruiting
University of Virginia Community Health
Culpeper, Virginia, 22701
- Active, not recruiting
Duke
Durham, North Carolina, 27710
- Recruiting
San Diego Clinical Trials
La Mesa, California, 91942
Brian Hamblen, 619-248-8517, brianhamblen@sdclinicaltrials.com
Mohamed Bidair, MD
- Recruiting
Comprehensive Urologic Care
Lake Barrington, Illinois, 60010
Sunny Clinical Research Coordinator, 847-382-5080, ssian@compurocare.com
Ning Wu, MD
- Enrolling by invitation
Nebraska Urology
Lincoln, Nebraska, 68516
- Enrolling by invitation
Arkansas Urology Research Center
Little Rock, Arkansas, 72211
- Recruiting
University of Miami Hospital
Miami, Florida, 33136
Elena Cortizas, 305-243-3593, ecortizas@med.miami.edu
Hemendra Shah, MD
- Recruiting
Arizona State Urological Research Institute
Phoenix, Arizona, 85225
Clinical Research Coordinator, 602-842-5305
Pratik Patel, MD
- Enrolling by invitation
Urology Nevada
Reno, Nevada, 89511
- Recruiting
University of Rochester Medical Center
Rochester, New York, 14620
Austin Jackson, 585-602-0556, austin.jackson@urmc.rochester.edu
Rajat Jain, MD
- Recruiting
Georgia Urology
Roswell, Georgia, 300076
Clinical Research Coordinator, 404-943-9654, researchteam@gaurology.com
Adam Mellis, MD
- Recruiting
Golden State Urology
Sacramento, California, 95823
Clinical Research Coordinator, 925-699-7545, ssethi@goldenstateurology.com
Prithipal Sethi, MD
- Recruiting
Urology San Antonio
San Antonio, Texas, 78229
Manuel Hernandez, 210-617-4116, manuel.hernandez@usa-clinicaltrials.com
Matthias Hofer, MD
- Enrolling by invitation
Urology Specialists Clinic
Sioux City, South Dakota, 57108
- Recruiting
SUNY - Upstate Medical University
Syracuse, New York, 13210
Diane Gould, 315-464-6105, gouldd@upstate.edu
Scott Wiener, MD
- Recruiting
Urology of Virginia
Virginia Beach, Virginia, 23462
Julia Csenar, 757-452-3463, jcsenar@urologyofva.net
James Young, MD
- Recruiting
Wichita Urology Group
Wichita, Kansas, 67226
Clinical Research Coordinator, 316-636-6100, tgentry@wichitaurology.com
Timothy Richardson, MD
- Recruiting
Minnesota Urology
Woodbury, Minnesota, 55125
Emmanuel Ogbu, 651-999-7032, eogbu@mnurology.com
Aaron Milbank, MD
About this study
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
- Kidney Calculi; Ureteral Calculi
- Being tested
- ELS (Enhanced Lithotripsy System)
- Medical subject headings
- Kidney Calculi, Ureteral Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ELS (Enhanced Lithotripsy System)Device
ELS (Enhanced Lithotripsy System) utilizes low pressure ultrasound to actuate proprietary microbubbles administered into the urine to pit and fragment urinary stones.
| Study group | Role | What they receive |
|---|---|---|
| The ELS Trial is a prospective, multi-center, single arm study. | Experimental | All Subjects who qualify to participate in the ELS Trial will receive the experimental ELS procedure. Receives: Device: ELS (Enhanced Lithotripsy System) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Outcome Measure
CT assessment of the target stone demonstrating either (i) stone free status (zero fragments) or (ii) the presence of only stone fragments small enough to pass spontaneously (<=4 mm) at 30 Days post procedure.
Measured: From ELS treatment to 30 Days afterward.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2025
- Study start1 May 2025
- Primary completionAug 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney Calculi; Ureteral CalculiStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 101 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Avvio Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06942949
- Sponsor's protocol ID
- CIP-0002
- Acronym
- ELS
- Status last verified
- Jul 2025
- First submitted
- 17 Apr 2025
- Last updated
- 16 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Enhanced Lithotripsy System (ELS) in the Treatment of Urinary Stones, A Pivotal Trial
- ClinicalTrials.gov ID
- NCT06942949
- Acronym / sponsor ID
- ELS / CIP-0002
- Conditions
- Kidney Calculi; Ureteral Calculi
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 101 participants (estimated)
- Lead sponsor
- Avvio MedicalIndustry (pharma, biotech, devices)
- Study start
- 1 May 2025 (actual)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 24 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| The ELS Trial is a prospective, multi-center, single arm study. | Experimental | Device: ELS (Enhanced Lithotripsy System)All Subjects who qualify to participate in the ELS Trial will receive the experimental ELS procedure. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ELS (Enhanced Lithotripsy System)ELS (Enhanced Lithotripsy System) utilizes low pressure ultrasound to actuate proprietary microbubbles administered into the urine to pit and fragment urinary stones. | Device | The ELS Trial is a prospective, multi-center, single arm study. |
Primary outcome
Primary Outcome Measure
Time frame: From ELS treatment to 30 Days afterward.
CT assessment of the target stone demonstrating either (i) stone free status (zero fragments) or (ii) the presence of only stone fragments small enough to pass spontaneously (<=4 mm) at 30 Days post procedure.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2026.
Related trials for Kidney Calculi; Ureteral Calculi
Not yet recruiting
Comparison of Smart Pressure-Controlled Flexible Ureteroscopy and Flexible Suction Ureteral Access Sheath-Assisted Flexible Ureteroscopy for 2-3 cm Renal Stones
Kidney Stones
RecruitingObservational study
Comparison of Suction and Conventional Ureteral Access Sheaths in Kidney Stone Surgery
Kidney Calculi, Nephrolithiasis
Not yet recruiting
Ureteral Access Strategies in Retrograde Intrarenal Surgery
Nephrolithiasis, Kidney Calculi
RecruitingObservational study
Renal Stone Treatment Global Registry
Urolithiasis
Active, not recruitingObservational study
Stone and Laser Therapies Post-Market Study (SALT)
Benign Prostate Hypertrophy(BPH), Renal Calculi
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ELS (Enhanced Lithotripsy System) in people with Kidney Calculi; Ureteral Calculi, run by Avvio Medical at 20 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Louis Marcoux (415-887-2037, louis.marcoux@avviomed.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Outcome Measure (time frame: From ELS treatment to 30 Days afterward.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2026.