Nanowear Heart Failure Management Multi-sensor Algorithm
NCT03719079 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 13
Last updated 2026-04-09
Summary
The NanoSense study is a multi-center, prospective, non-randomized, observational, feasibility, non-significant risk study. The NanoSense study will enroll up to 500 subjects in up to 10 centers in order to collect data which includes at least 150 heart failure hospitalizations in participating subjects.The duration of the NanoSense study is expected to be 2 years. The study device is the Wearable Congestive Heart Failure Management System (WCHFS, also known as SimpleSENSE)
Conditions
Interventions
- DEVICE
-
SimpleSENSE
The Nanosense study is observational only. No interventions will be triggered by the SimpleSense device
Sponsors & Collaborators
-
Milton S. Hershey Medical Center
collaborator OTHER -
Hackensack Meridian Health
collaborator OTHER -
Nanowear Inc.
lead INDUSTRY
Principal Investigators
-
John P Boehmer, M.D. · Milton S. Hershey Medical Center
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-08-21
- Primary Completion
- 2021-03-22
- Completion
- 2024-06-18
- FDA Device
- Yes
Countries
- United States
Study Locations
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