A First-in-Human Feasibility Study of the Vibrant Stroke Detection Technology During Carotid Endarterectomies
The goal of this observational study is to learn whether continuous carotid artery blood flow signals can be recorded reliably during surgery, and whether Vibrant Medical's analysis method can detect measurable changes in those signals, in adults undergoing elective carotid endarterectomy (CEA). During CEA, the surgeon temporarily clamps the internal carotid artery as a routine part of the operation. This produces a brief, controlled and fully reversible stop in blood flow that resembles the blood flow change seen in a large-vessel ischemic stroke.
The main questions it aims to answer are:
- Can usable, continuous blood flow signals be recorded from both sides of the neck before and during carotid clamping?
- Do the recorded signals show consistent, repeatable changes that are time-locked to carotid clamping and release across patients?
Participants will have their scheduled surgery as usual. During surgery, two legally marketed, FDA-cleared diagnostic ultrasound systems will record blood flow from the common carotid artery on each side of the neck, before clamping, during clamping and after the clamp is released, for about 20 to 30 minutes in total. The recordings are analyzed later and are not seen or used by the surgical team. No part of the surgery or anesthesia care is changed, and there are no study visits after surgery.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Background
In-hospital stroke is often recognized late, because patients may be sedated, anesthetized or otherwise unable to report symptoms, and there is currently no cleared device that continuously monitors carotid blood flow to flag a sudden change. Vibrant Medical is developing a wearable, non-invasive ultrasound sensor for this purpose. The element that is first-in-human in this study is Vibrant Medical's analysis method (wave-intensity and bilateral-asymmetry processing of carotid Doppler signals), which has previously been applied only to benchtop flow-phantom and in-vivo ovine data.
Carotid endarterectomy provides a controlled clinical model for this first human evaluation: the internal carotid artery clamp is applied and released by the surgeon as part of standard technique, producing a time-stamped, reversible reduction in carotid flow with no additional risk to the patient.
Study design
This is a prospective, single-center, single-arm, observational feasibility study at Tampa General Hospital / University of South Florida. Signals are acquired with two legally marketed, FDA-cleared Class II diagnostic ultrasound systems, one per side, each used within its cleared Peripheral Vessel indication.
Recording phases
- Baseline (pre-clamp): 1 to 2 minutes of continuous recording after stable signal acquisition and before any clamping.
- Internal carotid artery clamping: recording from just before clamp application through 1 to 2 minutes of clamping.
- Planned non-recording interval: both transducers are removed during arteriotomy, plaque removal and closure.
- Reperfusion: transducers are re-applied after closure, if this does not delay the surgical team, and recording continues from before clamp release through 1 to 2 minutes of restored flow.
No surgical step, including clamp timing, is delayed, modified or made contingent on the recordings. If a stable signal is not available when the surgeon is ready, the case proceeds unchanged and the phase is documented as missed.
Data collection and analysis
A study coordinator records time stamps of transducer placement, clamp application and release, and each recording phase on a case report form. Blood pressure, heart rate and the standard-of-care neuromonitoring data for the case are extracted from the anesthesia record and time-stamped to surgical events. Demographic and clinical variables (such as age, sex, BMI, surgical side and ASA class) are abstracted from the medical record. Recordings are exported and analyzed offline by Vibrant Medical research software labeled For Research Use Only; no output is available to the clinical team. Results are summarized descriptively; this feasibility study is not powered for hypothesis testing.
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Avennette Pinto
- Número de teléfono: 813-505-4787
- Correo electrónico: apinto3@usf.edu
Ubicaciones de estudio
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Florida
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Tampa, Florida, Estados Unidos, 33606
- Tampa General Hospital
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Investigador principal:
- Charles Briggs, MD
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Sub-Investigador:
- Jean Bismuth, MD
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Adult patients (18 years or older) scheduled for elective unilateral carotid endarterectomy at Tampa General Hospital, identified by the treating surgical team from the elective operative schedule and approached during a routine pre-surgical encounter.
Descripción
Inclusion Criteria:
- Adult patients 18 years of age or older.
- Scheduled to undergo elective unilateral carotid endarterectomy.
- Capable of providing written informed consent pre-operatively.
- No condition precluding placement of an ultrasound transducer at either side of the neck, as determined by the Investigator.
Exclusion Criteria:
- Emergency or urgent (non-elective) carotid endarterectomy.
- Planned simultaneous bilateral carotid endarterectomy, which would prevent contralateral recording.
- Known active neck wound, infection, or skin condition at the intended device application site.
- Implanted active device at the neck (e.g., vagal nerve stimulator) that could be affected by external ultrasound.
- Anatomy that prevents transducer contact at either side of the neck, as determined by the Investigator.
- Enrollment in another interventional clinical study that could confound device performance assessment.
- Pregnant patients, as determined by standard-of-care pregnancy testing performed prior to surgery.
- Patients who, in the investigator's judgment, are unable or unlikely to comply with the protocol or to provide valid informed consent.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: CASE_ONLY
- Perspectivas temporales: PROSPECTIVE
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
|
Elective Carotid Endarterectomy Patients
Adults undergoing elective unilateral carotid endarterectomy at Tampa General Hospital. Continuous bilateral common carotid Doppler signals are recorded intra-operatively at pre-clamp baseline, during internal carotid artery clamping, and at reperfusion, for approximately 20 to 30 minutes in total. Surgical and anesthesia care are not modified, and the recordings are not available to the clinical team. |
External, non-invasive recording of common carotid artery flow on both sides of the neck using two legally marketed, FDA-cleared Class II diagnostic ultrasound systems, one per side, each used within its cleared Peripheral Vessel indication: Telemed ArtUs EXT-2H with L12-5N40-A4 transducer (510(k) K211248) and Telemed SmartUs EXT-1M with L15-7L40H-5 transducer (510(k) K163121). Recordings are analyzed offline with Vibrant Medical research software (For Research Use Only). No output is shown to the surgical team and no clinical decision is based on the recordings. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Percentage of Subjects With Successful Bilateral Carotid Signal Acquisition During Baseline and Internal Carotid Artery Clamping
Periodo de tiempo: Intra-operative, from pre-clamp baseline through internal carotid artery clamping (single surgical encounter)
|
A subject is counted as a success when usable, continuous bilateral common carotid flow signal is acquired for the full duration of Phase 1 (pre-clamp baseline) and Phase 2 (internal carotid artery clamping), adjudicated against signal-quality criteria fixed before the first subject is enrolled. Subjects in whom acquisition fails are retained in the denominator. Reported as the percentage of enrolled subjects with an exact (Clopper-Pearson) 95% confidence interval, against a descriptive benchmark of at least 80%. This is not a hypothesis test. Phase 3 (reperfusion) is not part of this measure. |
Intra-operative, from pre-clamp baseline through internal carotid artery clamping (single surgical encounter)
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Percentage of Subjects With Successful Bilateral Carotid Signal Acquisition During Reperfusion
Periodo de tiempo: Intra-operative, from before clamp release through 1 to 2 minutes of reperfusion
|
Usable, continuous bilateral signal acquired for Phase 3, from before internal carotid artery clamp release through 1 to 2 minutes of restored flow. Reported descriptively and separately from the primary outcome, because both transducers are removed during the endarterectomy and re-application depends on not delaying the surgical team. |
Intra-operative, from before clamp release through 1 to 2 minutes of reperfusion
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Carotid Flow Signal Characteristics Time-Locked to Internal Carotid Artery Clamp Application and Release
Periodo de tiempo: Intra-operative, from pre-clamp baseline through reperfusion (single surgical encounter)
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Signal characteristics, including flow velocity, wave-intensity and bilateral-asymmetry measures, described per subject relative to the documented clamp application and release time stamps, and summarized descriptively. All enrolled subjects with any recorded data are included; no imputation is performed and missing phases are reported as missing. |
Intra-operative, from pre-clamp baseline through reperfusion (single surgical encounter)
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Charles Briggs, MD, Tampa General Hospital / University of South Florida
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- VM-FIH-CEA-01
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Individual participant data are coded, held under the data provisions of the clinical trial agreement, and are not planned for sharing. Aggregate study results will be made publicly available through publication or conference presentation.
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
producto fabricado y exportado desde los EE. UU.
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