RECRUITING

Nanowear Heart Failure Management Multi-sensor Algorithm

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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)

Official Title

The Nanowear Wearable Heart Failure Management System Multiple Sensor Algorithm Development and Validation Trial

Quick Facts

Study Start:2019-08-21
Study Completion:2024-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03719079

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Subject has provided informed consent
  2. * Male or female over the age of 18 years
  3. * The patient is either hospitalized with a primary diagnosis of acute or was discharged with a primary diagnosis of acute heart failure within 2 weeks prior to enrollment
  4. * NYHA functional class II-IV at time of enrollment
  1. * Subject unwilling or unable to comply with wearing the Nanowear Congestive Heart Failure Management System 12 hours daily for up to 90 days.
  2. * Subjects who are limited by angina.
  3. * Severe aortic stenosis.
  4. * Subjects who are hemodynamically unstable requiring support with intravenous vasoactive medications or mechanical circulatory support
  5. * Symptomatic ventricular arrhythmias within the past 6 months.
  6. * Subjects who are pregnant will be excluded from this study.

Contacts and Locations

Study Contact

John P Boehmer, M.D.
CONTACT
717-531-7453
jboehmer@pennstatehealth.psu.edu
Venkatesh Varadan
CONTACT
venk@nanowearinc.com

Principal Investigator

John P Boehmer, M.D.
PRINCIPAL_INVESTIGATOR
Milton S. Hershey Medical Center

Study Locations (Sites)

Penn State Health Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033
United States

Collaborators and Investigators

Sponsor: Nanowear Inc.

  • John P Boehmer, M.D., PRINCIPAL_INVESTIGATOR, Milton S. Hershey Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-08-21
Study Completion Date2024-12

Study Record Updates

Study Start Date2019-08-21
Study Completion Date2024-12

Terms related to this study

Keywords Provided by Researchers

  • Fluid decompensation
  • Non-invasive Multi-parameter monitoring
  • Multi-parameter algorithm
  • Heart Rate Variability
  • Thoracic impedance
  • Heart Sounds
  • Respiration
  • Posture
  • Activity
  • Tidal Volume
  • Stroke Volume

Additional Relevant MeSH Terms

  • Heart Failure