Status:
COMPLETED
Post-Market Surveillance With a Novel mHealth Platform
Lead Sponsor:
Yale University
Collaborating Sponsors:
Johnson & Johnson
Food and Drug Administration (FDA)
Conditions:
Gastrectomy
Atrial Fibrillation
Eligibility:
All Genders
18+ years
Brief Summary
This is a study to pilot the feasibility of using a novel patient-led, smartphone-based mobile health platform (Hugo) for real-world surveillance of outcomes of patients after they undergo a bariatric...
Detailed Description
The plan is to pilot test a novel patient-led, smartphone-based mobile health platform (called Hugo) for real-world surveillance of outcomes in 60 total patients after medical device use. Research ass...
Eligibility Criteria
Inclusion
- Age \>18
- English-speaking
- Planned for either a bariatric surgical procedure (either sleeve gastrectomy or gastric bypass) or catheter-based atrial fibrillation ablation
- Participant is willing and able to read and sign consent and participate in study
- Participant has an email account and a mobile device (smartphone or tablet) able to download the necessary applications
- Participant is willing to use the mobile health platform and syncable devices (e.g. Fitbit Charge 2)
- Attending bariatric surgeon or electrophysiologist (as appropriate) concurs that patient is a candidate for enrollment
Exclusion
- Healthy patients
- Patients who refuse participation
Key Trial Info
Start Date :
January 26 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 25 2018
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT03436082
Start Date
January 26 2018
End Date
December 25 2018
Last Update
March 19 2021
Active Locations (2)
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1
Yale New Haven Hospital
New Haven, Connecticut, United States, 06510
2
Mayo Clinic
Rochester, Minnesota, United States, 55905