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

Hypertension Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02337790
• Other study ID #: PERM-IRB-001-ICC
• Status: Completed
• Phase: N/A
• First received: January 9, 2015
• Last updated: December 28, 2015
• Start date: January 2015
• Est. completion date: May 2015

Study information

• Verified date: December 2015
• Source: toSense, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 109
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Heart Failure
• Hypertension

Locations

Country	Name	City	State
United States	Imperial Cardiac Center	Imperial	California

Sponsors (1)

Lead Sponsor	Collaborator
toSense, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Patients with Interference between implanted devices and CoVa Monitoring System		One time for up to 15 minutes during a clinic visit for device interrogation	No