Transkraniellt ultraljud via sonolucent kranioplastik
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.
Studieöversikt
Status
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Tamika Wong, MPH
- Telefonnummer: 212-434-4836
- E-post: twong4@northwell.edu
Studera Kontakt Backup
- Namn: Netanel Ben-Shalom, MD
- Telefonnummer: 212-434-3900
- E-post: nbenshalom@northwell.edu
Studieorter
-
-
New York
-
New York, New York, Förenta staterna, 10075
- Rekrytering
- Lenox Hill Hospital
-
Kontakt:
- Tamika Wong, MPH
- Telefonnummer: 212-434-4836
- E-post: twong4@northwell.edu
-
Underutredare:
- Tamika Wong, MPH
-
Underutredare:
- Olivia Albers, NP
-
Underutredare:
- Randy D'Amico, MD
-
Underutredare:
- Vadim Zhigin, PA
-
Kontakt:
- Netanel Ben-Shalom, MD
- Telefonnummer: 212-434-3900
- E-post: nbenshalom@northwell.edu
-
Underutredare:
- Heustein Sy, MD
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Diagnostisk
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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. |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Identification of Neuroanatomy accuracy of TCUS
Tidsram: 12 months
|
Accuracy metrics related to identification and measurement of neuroanatomy structures using Trasncranial Ultrasound |
12 months
|
|
Diagnostic accuracy of TCUS
Tidsram: 12 months
|
Accuracy metrics related to detection of postoperative complications using Trasncranial Ultrasound |
12 months
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Netanel Ben-Shalom, MD, Lenox Hill Hospital
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- 22-0873
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
Läkemedels- och apparatinformation, studiedokument
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