Vital Signs Validation Study of the μ-Cor System (ViVUS V... | NCT02975050

Studies
Vital Signs Validation Study of the μ-Cor System (ViVUS Validation)

NCT02975050

Sponsor

Zoll Medical Corporation

Status

Completed

Last Update Posted

Jul 7, 2020Actual

Enrollment

30Actual

Phase

Not provided

Conditions

Health Volunteer Validation Study

Interventions

Location

Countries

Not provided

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

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2020

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

Nov 28, 2016Actual

Primary Completion Date

Jan 19, 2017Actual

Completion Date

Jan 19, 2017Actual

First Submitted Date

Nov 22, 2016

First Submission Date that Met QC Criteria

Nov 23, 2016

First Posted Date

Nov 29, 2016Estimated

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

Jul 2, 2020

Last Update Posted Date

Jul 7, 2020Actual

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 has the following objective:

• To validate the capability of the μ-Cor System to monitor ECG, Heart Rate (HR), Respiration Rate (RR), Posture and Activity in healthy human subjects.

The μ-Cor validation will be demonstrated at two body locations:

Side location (below left armpit) for study arm 1, and
Front location (upper left chest) for study arm 2 An FDA-cleared comparator device will be used to support the validation of the study device.

Detailed Description

This study has the following objective:

• To validate the capability of the μ-Cor System to monitor ECG, Heart Rate (HR), Respiration Rate (RR), Posture and Activity in healthy human subjects.

The μ-Cor validation will be demonstrated at two body locations:

Side location (below left armpit) for study arm 1, and
Front location (upper left chest) for study arm 2 An FDA-cleared comparator device will be used to support the validation of the study device.

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

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Side location		u-Cor device will be applied on side location	Other: Location
Front location		u-Cor device will be applied on front location	Other: Location

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Location	Other		Front location Side location

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Respiratory rate	The difference between the μCor RR and the comparator RR will be lower than 2.8bpm (STD).	Immediately
Posture	90% agreement between the positions (supine / reclined / upright) derived from μCor reporting and the known position	Immediately
Activity	μCor output is provided as "active" and "not active". 90% correct classification of activity will be required of recordings.	Immediately
Heart Rate		Immediately
ECG		Immediately

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subject is at least 21 years of age or older.
Subject is willing and able to sign the Informed Consent Form.
Subject is healthy, able and willing to complete all the preparation steps and study procedures.

Exclusion Criteria

Female subject with a known pregnancy or unsure about pregnancy status.
Subjects with allergies and/or skin sensitivities to electrode hydrogel and/or acrylic based adhesive.
Subjects with skin breakdown in areas where device placement is required.
Subjects with chronic lung disease or asthma.
Subjects with a history of cardiovascular diseases.
Subjects who are diabetic.
Subjects living with kidney failure or dialysis.
Subjects with a history of liver failure.
Subjects with any known malignancy (i.e. cancer patients).
Subjects with implanted devices in the thoracic region

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Healthy volunteers

Sampling Method

Probability Sample

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Type	Date	Date Unknown
Release	Oct 11, 2022
Reset	Aug 29, 2023