Necklace-Shaped Sensor for Non-Invasive Remote Monitoring... | NCT02337790

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

NCT02337790

Sponsor

Baxter Healthcare Corporation

Status

Completed

Last Update Posted

Dec 30, 2015Estimated

Enrollment

109Actual

Phase

Not provided

Conditions

Heart Failure
Hypertension

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2015

Primary Completion Date

May 2015Actual

Completion Date

May 2015Actual

First Submitted Date

Jan 9, 2015

First Submission Date that Met QC Criteria

Jan 13, 2015

First Posted Date

Jan 14, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 28, 2015

Last Update Posted Date

Dec 30, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

The study had the following objectives:

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

109Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Cohort 1		Subjects will have a pacemaker, implanted cardioverter-defibrillator, or ventricular assist device.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Subjects will be from the Imperial Cardiac Clinic

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Matthew J Banet, PhD	Baxter Healthcare Corporation	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Imperial Cardiac Center		Imperial	California	92251	United States

Condition Browse Module

MeSH Terms

ID	Term
D006333	Heart Failure
D006973	Hypertension

Ancestor Terms

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D014652	Vascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided