Observational Study of Wearable Health Monitoring Device
Completed
Conditions studied: Weight Loss
In brief
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, respiration rate, posture, and activity. This device can be worn at the hospital and at home. The Healthdot will be able to send data and have good connectivity in a place where there is network coverage(4G/5G).
Key facts
- Study ID
- NCT05368389
- Run by
- Mayo Clinic
- People needed
- 33
- Starts
- 2022-11-03
- Expected to finish
- 2023-06-21
- Last updated by the study team
- 2024-03-28
Who can join
Age: 22 and older, up to 60. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Karl Akiki — Rochester, Minnesota, United States
Full record on ClinicalTrials.gov
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