Status:
COMPLETED
Observational Study of Wearable Health Monitoring Device
Lead Sponsor:
Mayo Clinic
Collaborating Sponsors:
Philips Healthcare
Conditions:
Weight Loss
Eligibility:
All Genders
22-60 years
Brief Summary
The purpose of this study is to better understand the use of Healthdot devices on bariatric patients in the USA. Healthdot is a wearable monitoring device that can collect data on heart rate, respirat...
Detailed Description
This clinical study is a single-center observational feasibility study of the Healthdot device, a wearable health monitoring device applied to bariatric surgery/endoscopy patients for in-hospital and ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 3 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 21 2023
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT05368389
Start Date
November 3 2022
End Date
June 21 2023
Last Update
March 28 2024
Active Locations (1)
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1
Karl Akiki
Rochester, Minnesota, United States, 55902