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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT02548624
Other study ID # COVMOPO0520
Secondary ID
Status Withdrawn
Phase N/A
First received September 1, 2015
Last updated April 4, 2017
Start date November 2016
Est. completion date February 2017

Study information

Verified date April 2017
Source Medtronic - MITG
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The primary objective of the study is to examine the effectiveness of the Zephyr BioPatch in measuring position changes of a non-patient subject in a lab setting and to examine the effectiveness of the Zephyr BioPatch in measuring position changes of hospitalized patients.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date February 2017
Est. primary completion date February 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria for Laboratory Subject:

1. Signed and dated informed consent by subject

2. Male or female of any race

3. At least 18 years of age

4. Willingness to have study device attached during study participation

5. Willingness to participate in all aspects of the study

Exclusion Criteria for Laboratory Subject:

1. Implanted pacemaker or defibrillator

2. Allergy or sensitivity to ECG leads or similar types of adhesive

3. History of hospital admission or a surgical procedure in the 60 days prior to study enrollment

4. BMI > 30.0

Inclusion Criteria for Hospital Subjects:

1. Signed and dated informed consent by subject

2. Male or female of any race

3. At least 18 years of age

4. Expected hospitalized admission on the general care floor for at least three days

5. At risk for hospital-acquired pressure ulcers as defined by score on the Braden Scale of < 18

6. Willingness to have study devices attached during study participation

7. Willingness to participate in all aspects of the study

Exclusion Criteria for Hospital Subjects:

1. Implanted pacemaker or defibrillator

2. Allergy or sensitivity to ECG leads or similar types of adhesive

3. Subject will be sleeping in a chair or spending the majority of time in a chair

4. BMI > 39.9

Study Design


Intervention

Device:
Zephyr BioPatch
The ZephyrLIFE Hospital System includes the BioPatch™ device (consisting of the BioModule™ sensor, BioModule™ holder, and snap ECG electrodes), the ECHO radio system, and a software monitoring interface. The BioModule™ sensor is a Class II device, 510(k) cleared by the FDA, and commercially available. The ZephyrLIFE Hospital System stores, transmits and displays vital sign data including ECG, HR, RR, body orientation, and activity to caregivers via a central station.

Locations

Country Name City State
United States Columbia University Medical Center New York City New York

Sponsors (1)

Lead Sponsor Collaborator
Medtronic - MITG

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Body position Body position will be classified as facing right, facing left, facing down (prone), or facing up (supine). During a 2.5 hour lab observation
Primary Body position Body position when lying horizontally will be classified as facing right, facing left, facing down (prone), or facing up (supine). During a 24 hospital observation
Secondary Performance of the Zephyr BioPatch position output in hospitalized patients of varying body mass indexes (BMI) Body position when lying horizontally will be classified as facing right, facing left, facing down (prone), or facing up (supine). During a 24 hospital observation.
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