NCT06942949ClinicalTrials.gov

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

מגייסמקבל משתתפים כעת, לפי רשומת המרשם.

יצירת קשר עם המחקר

בקצרה

התערבותידרושים 101 משתתפים20 אתריםמדינה אחת

קטגוריות

נפרולוגיה ואורולוגיה94%מיילדות וגינקולוגיה6%

רשום במרשם אחד

ClinicalTrials.govNCT06942949פתיחת רשומה זו ב־ClinicalTrials.govסונכרן לפני חודשיים

מחקר יחיד יכול להיות רשום בכמה מרשמים. אנו מציגים אותו פעם אחת ומקשרים לכל רשומה שברשותנו.

מידע הניסוי מוצג כפי שפורסם על ידי המרשם, בשפת המקור שלו.

מתעניינים במחקר הזה?

התחברות או צרו חשבון כדי לרשום את התעניינותכם ולעקוב אחר המחקר הזה.

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.

תקציר

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.

מצבים רפואיים

Kidney Calculi; Ureteral Calculi

זכאות

זכאות
מין	הכול
גילאים	21 Years – ללא מקסימום
מתנדבים בריאים	לא

זכאות כפי שנכתבה במרשם

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)

זכאות במשפטים פשוטים

הקריטריונים של רשומה זו טרם פורקו למשפטים נפרדים. טקסט המרשם שלמעלה שלם והוא הגרסה המחייבת.

תכנון המחקר

תכנון המחקר
סוג המחקר	התערבותי
שלב	לא רלוונטי
הקצאה	לא רלוונטי
מודל ההתערבות	SINGLE_GROUP
מטרה ראשית	TREATMENT
הסתרה	NONE (0)
גיוס	דרושים 101 משתתפים

נותן חסות ושותפים

Avvio Medical נותן חסות

זרועות והתערבויות

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.

התערבויות

התקן 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.

מדדי תוצאה

מדד תוצאה ראשוני
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.
מסגרת זמן From ELS treatment to 30 Days afterward.

תאריכים

תאריכים
תאריך התחלה	1 במאי 2025 (בפועל)
סיום ראשוני	1 באוגוסט 2026 (משוער)
סיום	1 בספטמבר 2026 (משוער)
פורסם לראשונה	24 באפריל 2025 (בפועל)
עודכן לאחרונה	16 ביוני 2026
התוצאות פורסמו	לא צוין ברשומת המרשם
המצב אומת לאחרונה	יולי 2025

בפועל פירושו שהאירוע התרחש. משוער פירושו שנותן החסות צופה אותו. שתי המשמעויות שונות זו מזו.

מיקומים

12 אתרים מגייסים

United States

United States
מתקן	עיר	מדינה או אזור	מצב
Michael G. Oefelein Clinical Trials	Bakersfield	California	פעיל, ללא גיוס
University of Virginia	Charlottesville	Virginia	בוטל
University of Virginia Community Health	Culpeper	Virginia	פעיל, ללא גיוס
Duke	Durham	North Carolina	פעיל, ללא גיוס
San Diego Clinical Trials	La Mesa	California	מגייס
Comprehensive Urologic Care	Lake Barrington	Illinois	מגייס
Nebraska Urology	Lincoln	Nebraska	לא צוין
Arkansas Urology Research Center	Little Rock	Arkansas	לא צוין
University of Miami Hospital	Miami	Florida	מגייס
Arizona State Urological Research Institute	Phoenix	Arizona	מגייס
Urology Nevada	Reno	Nevada	לא צוין
University of Rochester Medical Center	Rochester	New York	מגייס
Georgia Urology	Roswell	Georgia	מגייס
Golden State Urology	Sacramento	California	מגייס
Urology San Antonio	San Antonio	Texas	מגייס
Urology Specialists Clinic	Sioux City	South Dakota	לא צוין
SUNY - Upstate Medical University	Syracuse	New York	מגייס
Urology of Virginia	Virginia Beach	Virginia	מגייס
Wichita Urology Group	Wichita	Kansas	מגייס
Minnesota Urology	Woodbury	Minnesota	מגייס

מסמכי המחקר

לא צורפו מסמכים ברשומת מרשם זו.

שינויים לאורך זמן

לא נרשמו שינויים מאז שקלטנו רשומה זו לראשונה.

שינוי נרשם בכל פעם שנותן החסות מעדכן את רשומת המרשם. מצב, תאריכים, גיוס ואתרים מופיעים כאן ככל שהם משתנים.

מרשם: ClinicalTrials.gov · NCT########

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