Monitoring Subjects With Fluid-Management Issues In the Home Environment

Hypertension Clinical Trial

Official title:

A Study for Monitoring Subjects With Fluid-Management Issues Using Repeated Measurements In the Home Environment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02190877
• Other study ID #: Perm-IRB-001
• Status: Completed
• Phase: N/A
• First received: July 10, 2014
• Last updated: July 21, 2014
• Start date: April 2014
• Est. completion date: May 2014

Study information

• Verified date: July 2014
• 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 ease-of-use for the CoVa Monitoring System, along with simple statistical parameters such as reproducibility and inter-subject agreement between test and reference devices.

Description:

The study has the following objectives:

Objective 1: investigate ease-of-use associated with the CoVa Monitoring System: determine if subjects could use the test device on a daily basis, and if the components of this system (Sensor, Gateway, Web-based System) were indeed operational

Objective 2: determine if daily application of the Sensor's adhesive Electrodes resulted in any skin irritation

Objective 3: determine that the long-term reproducibility of measurements made by the test device is as good or better than the long-term reproducibility of the reference device

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 90 Years

Eligibility

Inclusion Criteria:

• Subject is between 21 (twenty-one) and 90 (ninety) years of age at screening.

• Subject will have a current prescription for a diuretic medication.

• 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 has a pacemaker, implanted cardioverter-defibrillator, or ventricular assist device.

• 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	Riverside Meadows	Riverside	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	Ease of Use	Investigate ease of use associated with the CoVa Monitoring System: determine if subjects could use the test device on a daily basis, and if the components of this system (Sensor, Gateway, Web-based System) were indeed operational	Each subject will be measured once per weekday over a 6 week period	No
Secondary	SKin irritation and reproducibility	Determine if subjects had skin irritation from daily use for 30 days. Determine the long-term reproducibility of the measurements from the test device versus the reference device	Each subject will be measured once per weekday over a 6 week period	No