NCT06942949ClinicalTrials.gov

Evaluation of Enhanced Lithotripsy System (ELS) in the Treatment of Urinary Stones, A Pivotal Trial

RecruitingTaking participants now, according to the registry record.

Contact this study

In brief

Interventional101 participants sought20 sites1 country

Registered in 1 registry

ClinicalTrials.govNCT06942949Open this record at ClinicalTrials.govSynced 2 months ago

One study can be registered in several registries. We show it once and link every record we hold.

Trial information is shown as published by the registry, in its original language.

Interested in this study?

How this study is set up

The points below are drawn from the public registry record for this study. Each one cites the field or sentence it came from. A dash (—) means the record does not state something — not that it is missing or wrong. Many well-run studies, especially small ones, leave some of these blank.

Present: Registered before enrolment beganFirst posted 2025-04-24; recorded start 2025-05-01
Present: Has a defined primary outcomeA primary outcome measure is listed in the record
Present: The primary outcome states a time frameThe primary outcome measure records a time frame
Not stated: Participants are not randomly assignedAllocation is recorded as non-randomised
Not stated: A comparison group is not stated in the registry recordThe record describes a single study arm
Not stated: Open label (no blinding)Masking is recorded as none (open label)
Not stated: An ethics committee is not stated in the registry recordThis registry's ingested record has no ethics-committee field
Not stated: Regulatory oversight (such as an IND or IDE) is not stated in the registry recordThis registry's ingested record has no regulatory-authorisation field
Not stated: A data monitoring committee is not stated in the registry recordThis registry's ingested record has no data-monitoring-committee fieldA data monitoring committee is not required for many smaller studies, and its absence here is not unusual.
Present: No cost to participants is mentioned in the recordChecked the summary, description and eligibility text; no cost-to-participant phrase found
Not stated: No other studies from this sponsor are in this databaseCounted from the lead sponsor named in the record (Avvio Medical)
Not stated: No posted results from this sponsor are in this database yetBased on the sponsor’s studies in this database

The record lists 1 condition.
Lead sponsor type recorded as: industry.

These are facts from the public registry record, not a judgement about the study. Discuss any trial with your own doctor before taking part.

What these facts mean, and what to ask · ruleset v1

Trial stature

Three independent measures of this study, described from its registry record — not a recommendation about it. A rigorous study by investigators nobody has heard of is better evidence than a weak study led by a famous one. How these are scored.

Methodological rigourEXPLORATORY

An exploratory-stage design for a study of this type, judged from its ClinicalTrials.gov record.

How this score is built

Randomised allocation0/20
Allocation not stated in the record
Blinding0/20
Open-label
Control arm0/15
No comparator arm stated in the record
Primary-outcome specificity10/10
Named primary outcome with a defined time frame
Endpoint type3/10
Surrogate or intermediate endpoint (conservative default)
Multi-centre8/8
Multi-centre: 20 sites
Data monitoring committee0/7
No data monitoring committee stated
Prospective registration5/5
Registered before the study start date
Protocol / SAP posted0/5
No protocol or SAP posted to the registry

ScaleSMALL

A small study: 101 participants (target), run at 20 sites.

How this score is built

Enrolment18/40
101 participants (target)
Site count15/25
20 sites
Country count0/15
Single country
Planned duration6/10
Planned over about 16 months
Sponsor scale0/10
Avvio Medical has led 1 trials in our corpus

Investigator standingUNKNOWN

We have no verifiable track record for the investigator named on this trial. That is common for early-career investigators and for records held outside ClinicalTrials.gov — it is not a negative signal.

How this score is built

Investigator standing0/100
No investigator recorded in the registry for this trial

These describe the registry record only, and today we hold ClinicalTrials.gov data. Absent fields lower a score, and absence often reflects registration practice rather than study quality. A high-stature trial is not necessarily safer or a better choice for you — enrolling in a large definitive trial can mean a higher chance of receiving placebo, while a small early-phase study may be the only route to a new therapy.

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

Kidney Calculi; Ureteral Calculi

Eligibility

Eligibility
Sex	All
Ages	21 Years – No maximum
Healthy volunteers	No

Eligibility as written in the registry

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)

Eligibility in plain statements

This record's criteria have not been broken into separate statements yet. The registry text above is complete and is the authoritative version.

Study design

Study design
Study type	Interventional
Phase	Not applicable
Allocation	Not applicable
Intervention model	SINGLE_GROUP
Primary purpose	TREATMENT
Masking	NONE (0)
Enrolment	101 participants sought

Sponsor and collaborators

Avvio Medical Sponsor

Arms and interventions

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.

Interventions

Device 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.

Outcome measures

Primary outcome
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.
Time frame From ELS treatment to 30 Days afterward.

Dates

Dates
Start date	May 1, 2025 (actual)
Primary completion	August 1, 2026 (estimated)
Completion	September 1, 2026 (estimated)
First posted	April 24, 2025 (actual)
Last updated	June 16, 2026
Results posted	Not stated in the registry record
Status last verified	July 2025

Actual means the event happened. Estimated means the sponsor expects it. The two mean different things.

Locations

12 sites are recruiting

United States

United States
Facility	City	State or region	Status
Michael G. Oefelein Clinical Trials	Bakersfield	California	Active, not recruiting
University of Virginia	Charlottesville	Virginia	Withdrawn
University of Virginia Community Health	Culpeper	Virginia	Active, not recruiting
Duke	Durham	North Carolina	Active, not recruiting
San Diego Clinical Trials	La Mesa	California	Recruiting
Comprehensive Urologic Care	Lake Barrington	Illinois	Recruiting
Nebraska Urology	Lincoln	Nebraska	Not stated
Arkansas Urology Research Center	Little Rock	Arkansas	Not stated
University of Miami Hospital	Miami	Florida	Recruiting
Arizona State Urological Research Institute	Phoenix	Arizona	Recruiting
Urology Nevada	Reno	Nevada	Not stated
University of Rochester Medical Center	Rochester	New York	Recruiting
Georgia Urology	Roswell	Georgia	Recruiting
Golden State Urology	Sacramento	California	Recruiting
Urology San Antonio	San Antonio	Texas	Recruiting
Urology Specialists Clinic	Sioux City	South Dakota	Not stated
SUNY - Upstate Medical University	Syracuse	New York	Recruiting
Urology of Virginia	Virginia Beach	Virginia	Recruiting
Wichita Urology Group	Wichita	Kansas	Recruiting
Minnesota Urology	Woodbury	Minnesota	Recruiting

Study documents

No documents are linked in this registry record.

Changes over time

No changes have been recorded since we first ingested this record.

A change is recorded each time the sponsor updates the registry record. Status, dates, enrolment and sites appear here as they move.

Registry: ClinicalTrials.gov · NCT########

https://xmedica.io/trials/ctgov/NCT06942949

Categories

Registered in 1 registry

Interested in this study?

How this study is set up

Summary

Conditions

Eligibility

Eligibility as written in the registry

Eligibility in plain statements

Study design

Sponsor and collaborators

Arms and interventions

Interventions

Outcome measures

Dates

Locations

United States

Study documents

Changes over time