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Sikkerhed og effektivitet af ultralydsfremdrivning af nyresten

29. maj 2026 opdateret af: Jonathan Harper, MD, University of Washington
En gennemførlighedsundersøgelse for at teste evnen til at flytte nyresten ved hjælp af fokuseret ultralyd. Det er målet med vores teknologi at: a) flytte stenfragmenter til et sted i nyren for at forbedre deres chancer for passage og dermed reducere forekomsten af ​​yderligere symptomatiske hændelser og genbehandling eller b) flytte en symptomatisk sten for at lindre symptomer og smerter .

Studieoversigt

Status

Aktiv, ikke rekrutterende

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Vores forskergruppe har udviklet en ny, ikke-invasiv teknologi, der bruger lavintensitetsfokuseret ultralyd til at genplacere nyresten ved at bibringe tilstrækkelig akustisk energi til fysisk at flytte en sten. De fokuserede ultralydsimpulser ligner impulser, der kan bruges i elastografi eller billeddannelse af akustisk strålingskraft. Ligesom konventionel ultralyd placeres sonden i kontakt med patientens hud for at afbilde stenen efter standard ultralydsbilledbehandlingsprocedure. Den samme sonde bruges derefter til at fokusere ultralyden og påføre et udbrud (en sekvens af impulser) af akustisk kraft for at skubbe stenen. Billeddannelse i lysstyrketilstand (B-tilstand) er sammenflettet med "skubbe"-impulser (Push-tilstand) for at overvåge stenbevægelser. Brugeren styrer burst-amplituden. Af hensyn til patientsikkerheden er der en lille forsinkelse, før operatøren kan udføre det næste tryk.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

172

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Washington
      • Seattle, Washington, Forenede Stater, 98108
        • VA Puget Sound Health Care System
      • Seattle, Washington, Forenede Stater, 98195
        • University of Washington Department of Urology

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Beskrivelse

Inklusionskriterier:

  • Personer, der præsenterer for University of Washington (UW) medicinske system eller Veterans Affairs Puget Sound sundhedssystem med mindst én nyresten eller stenfragment, der er synligt på nyre-ureter-blære (KUB) røntgen, computertomografi (CT), eller ultralydsscanning.
  • Personer, der er planlagt til en litotripsi-procedure
  • Personer, der møder op på klinikken eller skadestuen med en akut blokerende sten

Primære ekskluderingskriterier:

  • Personer under 18 år
  • Personer med ikke-ekkogene sten
  • Personer, der ikke kan eller vil overholde opfølgningskravene
  • Personer med koagulationsabnormitet eller som tager blodfortyndende medicin eller andre antikoagulantia ved klinisk signifikante niveauer
  • Personer med mobilitetsproblemer, som ikke er i stand til komfortabelt at ligge i op til 30 minutter eller rulle fra ryggen til siden Individer, der tilhører en sårbar gruppe (gravide, mentalt handicappede, fysisk handicappede, fanger osv.)

Derudover er der sekundære eksklusionskriterier for forsøgspersoner, der gennemgår en symptomatisk stenhændelse, som evalueres på tidspunktet for hændelsen.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Grundvidenskab
  • Tildeling: Ikke-randomiseret
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: First in Human (FIH)
Initial phase of the trial. Includes a broad spectrum of population groups (e.g. de novo, concurrent with URS, residual fragments) to demonstrate feasibility. Intervention consists of the non-invasive application of ultrasound to move stones within the kidney and ureter. Procedure conducted with the Propulse 1 device and C5-2 transducer. Subjects (n = 15) receive up to 40 push bursts.
Enhed: Propulse 1 with C5-2 probe
Move kidney stones with Propulse 1 device.
Eksperimentel: De Novo Small Stone
Segment of the trial focused specifically on subjects with small (≤ 5 mm) stones under observation management. Intervention consists of the non-invasive application of ultrasound to move stones within the kidney and ureter with the goal to facilitate passage. Procedure is conducted with the Propulse 1 device and SC-X transducer. Subjects (n = 2) receive multiple Push bursts up to a maximum cumulative dose exposure of 5 minutes. Each burst is a maximum of 3 seconds in duration and 200 W/cm2 in intensity.
Enhed: Propulse 1 with SC-X probe
Move kidney stones with Propulse 1 device.
Eksperimentel: Concurrent with URS
Segment of the trial focused specifically on subjects undergoing ultrasonic propulsion concurrently with their ureteroscopy guided laser lithotripsy procedure. Study provides visual observation of stone motion and any potential tissue injury. Intervention consists of the non-invasive application of ultrasound to move stones within the kidney and ureter. Procedure is conducted with the Propulse 1 device and SC-X transducer. Subjects (n = 18) receive multiple Push bursts up to a maximum cumulative dose exposure of 5 minutes. Each burst is a maximum of 3 seconds in duration and 200 W/cm2 in intensity.
Enhed: Propulse 1 with SC-X probe
Move kidney stones with Propulse 1 device.
Eksperimentel: Obstructing Stone - Pushing only
Segment of the trial focused specifically on subjects reporting to clinic or the emergency department with an obstructing stone. Intervention consists of the non-invasive application of ultrasound to relieve pain and facilitate passage. Procedure is conducted with the Propulse 1 device and SC-X transducer. Subjects (n = 16) receive multiple Push bursts up to a maximum cumulative dose exposure of 5 minutes. Each burst is a maximum of 3 seconds in duration and 200 W/cm2 in intensity.
Enhed: Propulse 1 with SC-X probe
Move kidney stones with Propulse 1 device.
Eksperimentel: Residual Fragment (Treatment group)
Segment of the trial focused specifically on subjects with small (≤ 5 mm) residual fragments following lithotripsy. This is the Treatment arm of a randomized control trial. Intervention consists of the non-invasive application of ultrasound to move stones within the kidney and ureter with the goal to facilitate passage. Procedure is conducted with the Propulse 1 device and SC-X transducer. Subjects (n = 54) receive multiple Push bursts up to a maximum cumulative dose exposure of 5 minutes. Each burst is a maximum of 3 seconds in duration and 200 W/cm2 in intensity.
Enhed: Propulse 1 with SC-X probe
Move kidney stones with Propulse 1 device.
Ingen indgriben: Residual Fragment (Control group)
Segment of the trial focused specifically on subjects with small (≤ 5 mm) residual fragments following lithotripsy. This is the Control arm of a randomized control trial. Subjects (n = 54) follow same protocol as Residual Fragment (Treatment group) but do not receive the ultrasonic propulsion intervention.
Eksperimentel: Obstructing Stone - Pushing + Dislodging
Segment of the trial focused specifically on subjects reporting to clinic or the emergency department with an obstructing stone. Participants were separate from the Obstructing Stone - Pushing only based on a stone skin-to-stone distance < 8 mm. Intervention consists of the non-invasive application of ultrasound to relieve pain and facilitate passage. Procedure is conducted with the Propulse 1 device and SC-X transducer. Subjects (n = 13) receive both Dislodging and Push bursts up to a maximum cumulative dose exposure of 5 minutes. This is the only population to receive the Dislodging bursts, which consist of higher amplitude (up to 7 MPa) and shorter duration pulses compared to pushing. The Push burst is a maximum of 3 seconds in duration and 200 W/cm2 in intensity.
Enhed: Propulse 1 with SC-X probe
Move kidney stones with Propulse 1 device.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Measurement of Stone Motion Caused by Ultrasound
Tidsramme: At the time of the procedure. To be evaluated with each therapy pulse over an approximately 1-hour study. Confirmed with post-procedure review of the study video.
Percentage of study participants for which stone motion was observed on the real-time ultrasound images.
At the time of the procedure. To be evaluated with each therapy pulse over an approximately 1-hour study. Confirmed with post-procedure review of the study video.
Measurement of Stone Passage
Tidsramme: Measurement occurs over 3 weeks (weekly phone call or email encounter with the subject) plus review of the subject's medical chart up to the point the subject is exited from the study.
The percentage of participants reporting visual observation of stone passage or confirmed with follow-up imaging. For the residual fragment RCT population specifically, the percentage of participants reporting visual observation of stone passage during the 3-week follow-up period after the procedure or randomization (Control group).
Measurement occurs over 3 weeks (weekly phone call or email encounter with the subject) plus review of the subject's medical chart up to the point the subject is exited from the study.
Measurement of Relapse
Tidsramme: Measurement up to 5 years post-procedure. This includes a phone call or email exchange semi-annually for up to 3-years and a medical record review (including imaging) semi-annually for up to 5-years.
The percentage of participants experiencing stone relapse defined as: an unscheduled, symptomatic visit for stones on the study side, surgery for stones on the study side, or stone growth of a residual fragment measured by clinical imaging exams. This measurement is specific to the residual fragment population and associated randomized control trial. Only a single relapse event is counted per participant, though a participant could experience more than one event.
Measurement up to 5 years post-procedure. This includes a phone call or email exchange semi-annually for up to 3-years and a medical record review (including imaging) semi-annually for up to 5-years.

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Måling af alle negative virkninger forbundet med proceduren
Tidsramme: Måling over 3 uger (ugentlig telefonopkald eller e-mail møde med emnet) plus gennemgang af emnets lægeskema.
Undersøgelsen måler frekvensen af ​​uønskede hændelser på emneniveau med indtræden efter proceduren (behandlingsgruppe) eller randomisering (kontrolgruppe) gennem den 3-ugers opfølgning, som af en blindet korrekturlæser er bestemt til at være potentielt relateret til enheden, proceduren eller forsøgspersonens underliggende nyresygdom. (Sekundært slutpunkt for begge SAP'er).
Måling over 3 uger (ugentlig telefonopkald eller e-mail møde med emnet) plus gennemgang af emnets lægeskema.

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of Participants With Discomfort Related to the Device or Procedure
Tidsramme: At the time of the procedure. To be evaluated over an approximately 1 hour study.

Pre-Procedure: The participant will be asked directly what discomfort, on a scale of 0 (no pain) to 10 (worst pain possible), they are experiencing and to point to where the discomfort/pain is located. This is the participant's recorded baseline measure.

During Procedure: The participant will be asked directly if they are experiencing any new or different discomfort, on a scale of 0 (no pain) to 10 (worst pain possible), and to point to where the discomfort/pain is located. Any new or different discomfort above baseline will be assumed related to the device or procedure; there is no minimum threshold for reporting.

Post Procedure: The participant will be asked directly what discomfort, on a scale of 0 (no pain) to 10 (worst pain possible), they are experiencing and to point to where the discomfort/pain is located. Any new or different discomfort above baseline will be assumed related to the device or procedure; there is no minimum threshold for reporting.
At the time of the procedure. To be evaluated over an approximately 1 hour study.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of Washington

Samarbejdspartnere

VA Puget Sound Health Care System

Efterforskere

  • Ledende efterforsker: Jonathan Harper, MD, University of Washington

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

17. december 2013

Primær færdiggørelse (Faktiske)

1. august 2025

Studieafslutning (Anslået)

31. maj 2026

Datoer for studieregistrering

Først indsendt

1. januar 2014

Først indsendt, der opfyldte QC-kriterier

5. januar 2014

Først opslået (Anslået)

7. januar 2014

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

1. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

29. maj 2026

Sidst verificeret

1. marts 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • STUDY00002746

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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Betingelser

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Placeringer

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