Post-Market Surveillance With a Novel mHealth Platform
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 17-009509
NCT ID: NCT03436082
Sponsor Protocol Number: 17-009509
About this study
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 sleeve gastrectomy and catheter-base atrial fibrillation ablation.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Age >18
- English-speaking
- Planned for either sleeve gastrectomy 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 Criteria:
- Healthy patients
- Patients who refuse participation
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Nilay Shah, Ph.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available