NCT02719301

Completed

Necklace-Shaped Sensor for Non-Invasive Monitoring of Stroke...

Baxter Healthcare Corporation Source

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Other study identifiers

Sponsor study identifier

PERM-IRB-001-CM

Study Type

observational

Actual enrollment (reported)

85

Locations

0 countries

Sites

N/A

Timeline

Study Start

September 2015

Actual (reported)

Primary Completion

January 2017

Actual (reported)

Study Completion

January 2017

Actual (reported)

Brief Summary

Study will compare measurements made with Necklace device for stroke volume/cardiac output with values from a FDA-approved reference device. The gold standard that will be used is Cardiac MRI. Subjects will be measured with both the Necklace, reference device, and the Cardiac MRI. Values calculated by the Cardiac MRI analysis will be compared with the reference device and the Necklace.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 85 participants
Study completion date: January 2017
Actual (reported)
Listed locations: 0 countries · 0 sites

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
September 2015
Actual (reported)
First Submitted
March 17, 2016
Actual (reported)
First Posted
March 25, 2016
Actual (reported)
Primary Completion
January 2017
Actual (reported)
Study Completion
January 2017
Actual (reported)

Last Updated: July 2, 2017
Status Verified: June 2017
Last Update Submitted: June 30, 2017

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

Comparison of Stroke Volume Measurement from Necklace with Cardiac MRI measurement of Stroke Volume
Retrospective up to 6 months after study completion

Study Arms (1)

Men/Women between 18 & 85

Accepting both healthy and non-healthy subjects. A portion of the subjects will have a fluid management issue or heart failure.

Eligibility Criteria

Age18 Years - 85 Years

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

Men and Women between 18 and 85.

You may qualify if:

Must be able to undergo Cardiac MRI

You may not qualify if:

Sponsors & Collaborators

Baxter Healthcare Corporation
Industrylead

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

Matthew J Banet
Baxter Healthcare Corporation
PRINCIPAL INVESTIGATOR

Enrollment

85 participants (actual enrollment reported by the registry).

Study Design

Study Type: observational
Observational Model: COHORT
Time Perspective: RETROSPECTIVE
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

March 17, 2016

First Posted

March 25, 2016

Study Start

September 2015

Actual (reported)

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Contact the study team to confirm eligibility.

Primary Completion

January 2017

Actual (reported)

Study Completion

January 2017

Actual (reported)

Last Updated

July 2, 2017

Record last verified: 2017-06

Data Sharing

IPD Sharing: Will not share

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT02719301
Data provider: ClinicalTrials.gov
Source updated: 2017-07-02
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:24:23 UTC

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Study Arms (1)

Men/Women between 18 & 85

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Data Sharing

Source record