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Post-Market Surveillance With a Novel mHealth Platform

NCT03436082 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 60

Last updated 2021-03-19

Study results available
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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 surgical procedure (either sleeve gastrectomy or gastric bypass) and catheter-based atrial fibrillation ablation

Conditions

Interventions

DEVICE

A mobile health platform

Patients pilot testing the smartphone based, mobile health platform called HUGO. Patients will also be given syncable devices to use that will provide additional insights into their health and health outcomes.Patients will be queried about specific symptoms related to their procedure at enrollment, one week post-procedure, at 4 weeks and again at 8 weeks.

Sponsors & Collaborators

  • Johnson & Johnson

    collaborator INDUSTRY

  • Food and Drug Administration (FDA)

    collaborator FED

  • Mayo Clinic

    collaborator OTHER

  • Yale University

    lead OTHER

Principal Investigators

  • Joseph Ross, MD · Yale University

  • Sanket Dhruva, MD · Yale University

  • Nilay Shah, PhD · Mayo Clinic

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-26
Primary Completion
2018-12-25
Completion
2018-12-25

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03436082 on ClinicalTrials.gov