Transkraniell ultralyd via sonolucent kranioplastikk
Transcranial Ultrasound via Sonolucent Cranioplasty is a prospective, single arm, observational, open label (non-blinded) study to collect real world evidence on the use of transcranial ultrasound via sonolucent cranioplasty.
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
Standard of care (SOC) imaging techniques routinely used for neurosurgical monitoring, namely computed tomography (CT) and magnetic resonance imaging (MRI), present numerous patient, provider, and institutional burdens associated with transport, invasiveness, contrast administration, radiation exposure, imaging delay, and overall global costs. Ultrasound represents a promising alternative that overcomes many of these disadvantages being noninvasive, low-risk, real-time and portable, but is limited by the acoustic impedance of autologous cranial bone. Recently, material innovations enabling both transparent and sonolucent polymethyl methacrylate (PMMA) - a material commonly used for cranial reconstruction with a longstanding history of safety - have facilitated ultrasound windows within patients already receiving cranioplasty as standard of care. Early results applying transcranioplasty ultrasound (TCUS) through sonolucent cranial plates have been encouraging in regard to agreement with SOC imaging and advanced doppler capabilities. That said, limited published data exists commensurate with the novelty of the technique, therefore investigators herein aim to address this paucity by investigating the feasibility and efficacy of TCUS as compared to standard of care postoperative imaging modalities (i.e. MRI & CT) in a prospective, quality control study.
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Tamika Wong, MPH
- Telefonnummer: 212-434-4836
- E-post: twong4@northwell.edu
Studer Kontakt Backup
- Navn: Netanel Ben-Shalom, MD
- Telefonnummer: 212-434-3900
- E-post: nbenshalom@northwell.edu
Studiesteder
-
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New York
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New York, New York, Forente stater, 10075
- Rekruttering
- Lenox Hill Hospital
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Ta kontakt med:
- Tamika Wong, MPH
- Telefonnummer: 212-434-4836
- E-post: twong4@northwell.edu
-
Underetterforsker:
- Tamika Wong, MPH
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Underetterforsker:
- Olivia Albers, NP
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Underetterforsker:
- Randy D'Amico, MD
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Underetterforsker:
- Vadim Zhigin, PA
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Ta kontakt med:
- Netanel Ben-Shalom, MD
- Telefonnummer: 212-434-3900
- E-post: nbenshalom@northwell.edu
-
Underetterforsker:
- Heustein Sy, MD
-
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Provision of signed and dated informed consent form.
- Stated willingness to comply with all study procedures and availability for the duration of the study.
- Patients who are undergoing reconstructive sonolucent cranioplasty as standard of care.
- Male or female, aged ≥ 18.
Exclusion Criteria:
1. Patients who are pregnant
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Diagnostisk
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Transcranial Ultrasound
Ultrasound imaging will be performed by clinicians using FDA-approved ultrasound devices currently used in routine clinical practice. |
Patients who underwent reconstructive sonolucent cranioplasty will receive standard of care postoperative imaging (i.e. CT, MRI) in addition to ultrasound imaging. Ultrasound imaging will be performed by clinicians using FDA-approved ultrasound devices (GE Venue Go, Fujifilm Sonosite X-Porte, GE Volusion E10 and Clarius HD3 etc.) currently used in routine clinical practice. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Identification of Neuroanatomy accuracy of TCUS
Tidsramme: 12 months
|
Accuracy metrics related to identification and measurement of neuroanatomy structures using Trasncranial Ultrasound |
12 months
|
|
Diagnostic accuracy of TCUS
Tidsramme: 12 months
|
Accuracy metrics related to detection of postoperative complications using Trasncranial Ultrasound |
12 months
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Netanel Ben-Shalom, MD, Lenox Hill Hospital
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- 22-0873
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
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