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Necklace-Shaped Sensor for Non-Invasive Remote Monitoring of Vitals

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ClinicalTrials.gov Identifier: NCT02337790
Recruitment Status : Completed
First Posted : January 14, 2015
Last Update Posted : December 30, 2015
Sponsor:
Information provided by (Responsible Party):
toSense, Inc.

Brief Summary:
This study is designed to validate the use of the CoVa Monitoring System in subjects with implanted devices.

Condition or disease
Heart Failure Hypertension

Detailed Description:

The study had the following objectives:

  1. Verify that the CoVa Monitoring System does not interfere with implanted devices.
  2. Verify that implanted devices do not interfere with the functions of the CoVa Monitoring System.
  3. Verify that the CoVa Monitoring System fits on a wide variety of body types.

Study Type : Observational
Actual Enrollment : 109 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Necklace-Shaped Sensor for Non-Invasive Monitoring of Fluids, Heart Rate, Heart Rate Variability, and Respiration Rate in Patients With a Pacemaker, Implanted Cardioverter-Defibrillator, or Ventricular Assist Device
Study Start Date : January 2015
Actual Primary Completion Date : May 2015
Actual Study Completion Date : May 2015

Group/Cohort
Cohort 1
Subjects will have a pacemaker, implanted cardioverter-defibrillator, or ventricular assist device.



Primary Outcome Measures :
  1. Number of Patients with Interference between implanted devices and CoVa Monitoring System [ Time Frame: One time for up to 15 minutes during a clinic visit for device interrogation ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects will be from the Imperial Cardiac Clinic
Criteria

Inclusion Criteria:

  • Subject is between 21 (twenty-one) and 95 (ninety-five) years of age at screening.
  • Subject has a pacemaker, implanted cardioverter-defibrillator, or ventricular assist device.
  • Subject and/or legally authorized person/representative is willing to undergo the Informed Consent process prior to enrollment in the study.
  • Subject is a candidate for this study based on the PI's opinion and knowledge of the subject's condition.

Exclusion Criteria:

  • Subject is participating in another clinical study that may affect the results of either study.
  • Subject is unable or not willing to wear electrode patches as required.
  • Subject has skin sensitivity to adhesive or hydrogel materials used in electrode patches.
  • Subject is considered by the PI to be medically unsuitable for study participation.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02337790


Locations
United States, California
Imperial Cardiac Center
Imperial, California, United States, 92251
Sponsors and Collaborators
toSense, Inc.
Investigators
Principal Investigator: Matthew J Banet, PhD toSense, Inc.

Responsible Party: toSense, Inc.
ClinicalTrials.gov Identifier: NCT02337790     History of Changes
Other Study ID Numbers: PERM-IRB-001-ICC
First Posted: January 14, 2015    Key Record Dates
Last Update Posted: December 30, 2015
Last Verified: December 2015

Keywords provided by toSense, Inc.:
Hypertension
Heart Failure
Fluids

Additional relevant MeSH terms:
Hypertension
Heart Failure
Vascular Diseases
Cardiovascular Diseases
Heart Diseases