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Observational Study of Wearable Health Monitoring Device

Overview

Información sobre este estudio

The purpose of this study is to assess if a larger interventional study is possible.  This study will follow subjects wearing a small device  that sticks to the skin temporarily to collect vitals information. This information is routed by 4G/5G wireless technology to a secured data system on the internet accessable by study team and funding sponsor personnel without any personally identifiable information for the assessment of connectivity, accuracy, and usefullness as compared to current health monitoring systems in clinical use both on-site at the hospital and at home. 

Elegibilidad para la participación

Los requisitos de elegibilidad de los participantes incluyen la edad, el sexo, el tipo y el estadio de la enfermedad, y los problemas de salud o tratamientos previos. Las pautas difieren de un estudio a otro e identifican quiénes pueden o no pueden participar. No hay garantía de que cada persona elegible que desee participar en un ensayo se inscribirá. Comunícate con el equipo del estudio para analizar la elegibilidad del estudio y la posible participación.

Inclusion Criteria:  

  • Age 22 to 60.
  • Patients being seen for upcoming planned weight-loss procedure (ESG, Balloon, Bariatric Surgery, Revision after Bariatric Surgery).
  • Commitment to wear device without removing for entire study period.
  • Located within a driving distance from Mayo Clinic in Rochester, Minnesota during study duration.
  • Reside in an area with 4G or 5G connectivity based on cellphone provider maps for T-Mobile or AT&T.
  • Subject clear of any dermatologic health diagnosis that may impede the ability of the device to adhere properly.

Exclusion Criteria:   

  • Unable to give consent.
  • Unwillingness to utilize email address for device instructions, surveys, and reminders.
  • Lifestyle that would have the device exposed to excessive elements for a prolonged period of time outside the parameters of normal operation of the device.
  • Patient is expected/anticipated to fly (use an airplane) before study completion (before Day 10).
  • Subjects with a pacemaker or an implanted electronic device.
  • Subjects scheduled or likely to conduct MRI within the study period.
  • Left lower rib (place where Healthdot will be applied) is involved in the area of surgery, area of disinfection or area where bandages are needed.
  • Patients with severe systemic diseases.

Eligibility last updated 2/24/22. Questions regarding updates should be directed to the study team contact.

 

Sedes participantes de Mayo Clinic

Los estatus de los estudios cambian con frecuencia. Comunícate con el equipo del estudio para obtener la información más actualizada acerca de la posibilidad de participar.

Sede de Mayo Clinic Estatus Contacto

Rochester, Minn.

Investigador principal de Mayo Clinic

Eric Vargas Valls, M.D., M.S.

Cerrado para la inscripción

Contact information:

Karim Al Annan M.D.

(507) 284-4723

AlAnnan.Karim@mayo.edu

More information

Publicaciones

Publications are currently not available

Otros temas en investigación

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CLS-20537138

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