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Portable Ultrasound for Interventional Procedures

24. december 2020 opdateret af: Ralph Weissleder, MD, Massachusetts General Hospital
We are evaluating whether a portable ultrasound can be safely and effectively used in portable interventional procedures, whether the image quality can be improved to meet standard existing ultrasounds. In the COVID-19 pandemic, transferring patients with COVID-19 to the procedure room results in contamination and shut down of those rooms while also putting folks in transit at some degree of transmission risk. The ability to do procedures at bedside can alleviate those risks greatly.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Portable ultrasound-guided procedures, including paracentesis, thoracentesis, drain placement, or simple biopsies can be required for patients who are difficult to move, in particular COVID-19 patients, patients in the ICU, or on the floor. Portable ultrasounds have demonstrated a convenient ability to provide a point of care ultrasound diagnostic testing with expanding use in standard clinical care. A number of portable ultrasound systems are in routine clinical use at MGH and have been used for diagnostic procedures (e.g. Butterfly, Hologic, others). Most of the systems are still tethered (transducer is connected via cables to a computer or power) which may represent challenges for contamination, especially in interventional procedures. The Healcerion system is the first FDA approved wireless and battery-operated portable ultrasound system of its kind and is in routine use for diagnostic ultrasounds throughout the world.

The goal of the current study is to compare the utility and practical operations of the advanced Healcerion SONON ultrasound system to a standard wheeled and bulky ultrasound systems in current use (Hitachi, GE). While the Healcerion device has been used at other institutions, it has not been used for interventional procedures at MGH. A comparative efficacy study will allow the investigators to examine the safety and efficacy of the device to complete procedures in a portable setting as well as explore whether images can be improved to reach the more robust imaging capability of wired devices.

Undersøgelsestype

Observationel

Tilmelding (Forventet)

200

Kontakter og lokationer

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

Studiekontakt

Undersøgelse Kontakt Backup

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 til 120 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Sandsynlighedsprøve

Studiebefolkning

Adult patients undergoing an ultrasound-guided procedure, such as paracentesis, thoracentesis, or biopsy

Beskrivelse

Inclusion Criteria:

  • The subject has read, signed, and dated the Informed Consent Form (ICF), having been advised of the risks and benefits of the trial in a language understood by the subject.
  • Age ≥ 18 years at the date of informed consent form signature and having the ability to comply with the protocol.
  • Undergoing a clinically indicated ultrasound-guided procedure, such as paracentesis, thoracentesis, or biopsy.

Exclusion Criteria:

  • Patient or health care proxy does not consent
  • Patient not undergoing an ultrasound-guided procedure.

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
Adult patients undergoing an ultrasound-guided procedure
Adult patients undergoing an ultrasound-guided procedure, such as paracentesis, thoracentesis, or biopsy
Procedure: Ultrasound guided procedure
Single-arm, open-label device efficacy study to enroll 200 patients who have been ordered to have an ultrasound-guided procedure by the MGH Interventional Radiology department, including paracentesis, thoracentesis, biopsy, or ultrasound-guided drain placement. Patients will be restricted to adults who can consent.
Enhed: Portable ultrasound
The FDA approved Healcerion SONON portable ultrasound (linear and curved) will be used during clinically indicated standard ultrasound-guided procedures following clinical standard of care. A standard clinical ultrasound will subsequently be used for image guidance as the gold standard. Images will be compared and improved. The efficacy of the portable ultrasound will be monitored by the clinical user and any complications within 30 days will be determined by chart review.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Efficacy > 80%
Tidsramme: Approximately 3 years
Efficacy as defined by the operator in successfully completing the procedure using the portable ultrasound. Reported % of cases the portable ultrasound successfully completed the procedure, stratified by procedure type.
Approximately 3 years

Samarbejdspartnere og efterforskere

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

Sponsor

Massachusetts General Hospital

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 (Forventet)

1. januar 2021

Primær færdiggørelse (Forventet)

31. december 2023

Studieafslutning (Forventet)

31. december 2023

Datoer for studieregistrering

Først indsendt

22. december 2020

Først indsendt, der opfyldte QC-kriterier

24. december 2020

Først opslået (Faktiske)

28. december 2020

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

28. december 2020

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

24. december 2020

Sidst verificeret

1. december 2020

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • 2020P003984

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ja

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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