A Wearable Biosensor Patch for Non-Invasive Monitoring for Patients Undergoing Abdominal or Chest Surgery
21 de mayo de 2026 actualizado por: City of Hope Medical Center
Pilot Study on the Clinical Application of a Wearable Biosensor Patch for Non-Invasive Measurement of Biochemical and Blood Gas Analytes
This clinical trial tests the feasibility and safety of a wearable biosensor patch for non-invasive monitoring for patients undergoing abdominal or chest surgery.
Wearable biosensor patches have been developed by researchers to provide a non-invasive way to monitor substances that are normally checked using blood tests.
This may reduce the need for frequent blood draws.
The patches use gentle electrical stimulation to produce sweat and tiny built-in sensors to measure substances such as glucose, creatinine, and markers of inflammation, as well as oxygen and carbon dioxide levels.
The wearable biosensor patch may be a feasible and safe way to monitor patients undergoing abdominal or chest surgery.
Descripción general del estudio
Estado
Aún no reclutando
Descripción detallada
PRIMARY OBJECTIVE:
I. To evaluate the feasibility of data collection using wearable postoperative biosensor patch.
SECONDARY OBJECTIVES:
I. To evaluate patient acceptability with using the wearable biosensor patch. II. To evaluate the safety of the wearable biosensor patch. III. To assess processes and resources needed to deploy the wearable biosensor patches postoperatively.
EXPLORATORY OBJECTIVES:
I. To explore the consistency of sweat analyte concentrations obtained using the wearable biosensor patch and a standard sweat collector.
II. To explore the accuracy of sweat-derived analyte concentrations relative to peripheral blood measurements (gold standard).
III. To explore the feasibility of intraoperative blood gas monitoring using a transcutaneous biosensor patch measuring oxygen (O₂) and carbon dioxide (CO₂).
IV. To explore the accuracy of O₂ and CO₂ concentrations obtained from the transcutaneous biosensor patch relative to paired intraoperative blood gas measurements (gold standard).
OUTLINE:
Patients have the wearable biosensor patch placed on the upper back or shoulder during surgery and wear it for the duration of the surgery to monitor oxygen and carbon dioxide levels. Starting the day after surgery, patients wear a biosensor patch on their wrist along with a sweat collecting chamber for 2-4 hours, up to twice daily, for up to 3 days post-operatively.
After completion of study intervention, patients may be followed up for up to 1 year.
Tipo de estudio
Intervencionista
Inscripción (Estimado)
20
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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California
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Duarte, California, Estados Unidos, 91010
- City of Hope Medical Center
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Contacto:
- Kelly Mahuron
- Número de teléfono: 89200 626-256-4673
- Correo electrónico: kmahuron@coh.org
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Investigador principal:
- Kelly Mahuron
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
Inclusion Criteria:
- Age ≥ 18 years
- Scheduled to have an elective abdominal or thoracic operation with anticipated post-operative hospitalization ≥ 3 days
- Willingness to provide sweat samples, complete surveys, and permit review of medical records for research use
- Ability to consent to the study procedures
Exclusion Criteria:
- Carbachol or pilocarpine allergy
- Adhesive/tape allergy
- Damaged or irritated skin on one or both wrists that prohibits placement of the biosensor and sweat collecting devices
- Pregnant women
- Children less than 18 years of age
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Diagnóstico
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Diagnostic (wearable biosensor patch)
Patients have the wearable biosensor patch placed on the upper back or shoulder during surgery and wear it for the duration of the surgery to monitor oxygen and carbon monoxide levels.
Starting the day after surgery, patients wear a biosensor patch on their wrist along with a sweat collecting chamber for 2-4 hours, up to twice daily, for up to 3 days post-operatively.
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Estudios complementarios
Estudios complementarios
Estudios complementarios
Undergo sweat sample collection
Otros nombres:
Wear biosensor patch
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Proportion of successful sweat collections (feasibility)
Periodo de tiempo: Up to 1 year
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A successful collection will be defined by patch application with data successfully recorded and sent to the database.
Examples of failed collections include, but are not limited to, a patch falling off before data collection can occur or a patch failing to collect and send data to the database.
The number of successful collections will be reported as a proportion of the total number of attempted applications.
All analyses will be descriptive.
Unless otherwise specified, continuous variables will be summarized with mean, standard deviation, median, interquartile range, minimum, and maximum; categorical variables with counts and percentages.
Given the small sample, two-sided 95 percent exact (Clopper-Pearson) confidence intervals will be provided for proportions.
In addition to the overall success rate, the success rates for each type of patch (intraoperative and postoperative) will be described.
All causes of failure (including unknown causes) will be reported.
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Up to 1 year
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Acceptability of the intervention
Periodo de tiempo: Up to 1 year
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Assessed using Acceptability of Intervention Measure (AIM) scores and qualitative data analysis of patient exit interviews.
Scores will be summarized descriptively.
Exit interviews will be conducted to explore subjective experience with the biosensor patch.
Topics will include comfort/discomfort while wearing the patch, comfort/discomfort during application and removal, and open-ended feedback.
All analyses will be descriptive.
Unless otherwise specified, continuous variables will be summarized with mean, standard deviation, median, interquartile range, minimum, and maximum; categorical variables with counts and percentages.
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Up to 1 year
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Incidence of treatment related adverse events related to biosensor use
Periodo de tiempo: Up to 1 year
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Safety will be evaluated based on the incidence of treatment-emergent adverse events deemed definitely, probably, or possibly related to the biosensor device.
Adverse events will be graded using the Common Terminology Criteria for Adverse Events version 5.0.
All analyses will be descriptive.
Unless otherwise specified, continuous variables will be summarized with mean, standard deviation, median, interquartile range, minimum, and maximum; categorical variables with counts and percentages.
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Up to 1 year
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Processes and resources needed to deploy the wearable biosensor patches postoperatively
Periodo de tiempo: Up to 1 year
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Processes and resources needed to deploy the biosensor patches will be assessed through one focus group.
Topics will include: approximate time to setting up the patch for patients and applying them, barriers and facilitators in deploying the patches, and open-ended feedback.
All analyses will be descriptive.
Unless otherwise specified, continuous variables will be summarized with mean, standard deviation, median, interquartile range, minimum, and maximum; categorical variables with counts and percentages.
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Up to 1 year
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Kelly Mahuron, City of Hope Medical Center
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
2 de septiembre de 2026
Finalización primaria (Estimado)
15 de abril de 2027
Finalización del estudio (Estimado)
15 de abril de 2027
Fechas de registro del estudio
Enviado por primera vez
21 de mayo de 2026
Primero enviado que cumplió con los criterios de control de calidad
21 de mayo de 2026
Publicado por primera vez (Actual)
28 de mayo de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
28 de mayo de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
21 de mayo de 2026
Última verificación
1 de mayo de 2026
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Calidad, acceso y evaluación de la atención médica
- Técnicas de investigación
- Métodos epidemiológicos
- Técnicas de laboratorio clínico
- Técnicas y procedimientos de diagnóstico
- Diagnóstico
- Recopilación de datos
- Mecanismos de evaluación de atención médica
- Calidad de la atención médica
- Salud pública
- Medio ambiente y salud pública
- Entrevistas como tema
- Manejo de muestras
Otros números de identificación del estudio
- 25132 (Otro identificador: City of Hope Medical Center)
- P30CA033572 (Subvención/contrato del NIH de EE. UU.)
- NCI-2026-03601 (Identificador de registro: CTRP (Clinical Trial Reporting Program))
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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