NCT06942949ClinicalTrials.gov
Evaluation of Enhanced Lithotripsy System (ELS) in the Treatment of Urinary Stones, A Pivotal Trial
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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…
Interventionell101 Teilnehmende gesucht20 Studienzentren1 Land
Kategorien
In 1 Register registriert
- ClinicalTrials.govNCT06942949Diesen Eintrag bei ClinicalTrials.gov öffnenSynchronisiert vor 2 Monaten
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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.
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.
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
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
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.
Zusammenfassung
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.
Erkrankungen
- Kidney Calculi; Ureteral Calculi
Eignung
| Geschlecht | Alle |
|---|---|
| Alter | 21 Years – Kein Höchstalter |
| Gesunde Freiwillige | Nein |
Eignung im Wortlaut des Registers
Eignung in einfachen Aussagen
Die Kriterien dieses Eintrags wurden noch nicht in einzelne Aussagen aufgeschlüsselt. Der Registertext oben ist vollständig und ist die maßgebliche Fassung.
Studiendesign
| Studientyp | Interventionell |
|---|---|
| Phase | Nicht zutreffend |
| Zuteilung | Nicht zutreffend |
| Interventionsmodell | SINGLE_GROUP |
| Primäres Ziel | TREATMENT |
| Verblindung | NONE (0) |
| Teilnahme | 101 Teilnehmende gesucht |
Sponsor und Mitwirkende
- Avvio Medical Sponsor
Studienarme und Interventionen
- 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.
Interventionen
- Medizinprodukt 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.
Endpunkte
Primärer Endpunkt
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.
Zeitrahmen From ELS treatment to 30 Days afterward.
Daten
| Startdatum | 1. Mai 2025 (tatsächlich) |
|---|---|
| Primärer Abschluss | 1. August 2026 (geschätzt) |
| Abschluss | 1. September 2026 (geschätzt) |
| Erstveröffentlichung | 24. April 2025 (tatsächlich) |
| Zuletzt aktualisiert | 16. Juni 2026 |
| Ergebnisse veröffentlicht | Im Registereintrag nicht angegeben |
| Status zuletzt bestätigt | Juli 2025 |
Tatsächlich bedeutet, dass das Ereignis eingetreten ist. Geschätzt bedeutet, dass der Sponsor es erwartet. Die beiden bedeuten Unterschiedliches.
Standorte
12 Studienzentren rekrutieren
United States
| Einrichtung | Stadt | Bundesland oder Region | Status |
|---|---|---|---|
| Michael G. Oefelein Clinical Trials | Bakersfield | California | Aktiv, rekrutiert nicht |
| University of Virginia | Charlottesville | Virginia | Zurückgezogen |
| University of Virginia Community Health | Culpeper | Virginia | Aktiv, rekrutiert nicht |
| Duke | Durham | North Carolina | Aktiv, rekrutiert nicht |
| San Diego Clinical Trials | La Mesa | California | Rekrutiert |
| Comprehensive Urologic Care | Lake Barrington | Illinois | Rekrutiert |
| Nebraska Urology | Lincoln | Nebraska | Nicht angegeben |
| Arkansas Urology Research Center | Little Rock | Arkansas | Nicht angegeben |
| University of Miami Hospital | Miami | Florida | Rekrutiert |
| Arizona State Urological Research Institute | Phoenix | Arizona | Rekrutiert |
| Urology Nevada | Reno | Nevada | Nicht angegeben |
| University of Rochester Medical Center | Rochester | New York | Rekrutiert |
| Georgia Urology | Roswell | Georgia | Rekrutiert |
| Golden State Urology | Sacramento | California | Rekrutiert |
| Urology San Antonio | San Antonio | Texas | Rekrutiert |
| Urology Specialists Clinic | Sioux City | South Dakota | Nicht angegeben |
| SUNY - Upstate Medical University | Syracuse | New York | Rekrutiert |
| Urology of Virginia | Virginia Beach | Virginia | Rekrutiert |
| Wichita Urology Group | Wichita | Kansas | Rekrutiert |
| Minnesota Urology | Woodbury | Minnesota | Rekrutiert |
Studiendokumente
In diesem Registereintrag sind keine Dokumente verlinkt.
Änderungen im Zeitverlauf
Seit wir diesen Eintrag erstmals eingelesen haben, wurden keine Änderungen erfasst.
Eine Änderung wird jedes Mal erfasst, wenn der Sponsor den Registereintrag aktualisiert. Status, Daten, Teilnahme und Studienzentren erscheinen hier, sobald sie sich ändern.