Collection of Anatomical and Reference Data for Development of a Novel Non-Invasive Lung Hydration Status Technology



Status:Completed
Conditions:Healthy Studies
Therapuetic Areas:Other
Healthy:No
Age Range:30 - Any
Updated:4/21/2016
Start Date:April 2015
End Date:September 2015

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Trial Summary
Trial Overview
Inclusion Criteria
This study will be conducted to collect anatomical data in an ambulatory healthy population
to aid in the development of a novel non-invasive technology to assess changes in lung
hydration status. It will also help in developing reference ranges of lung hydration status
in healthy subjects and their associated changes with time.


Inclusion Criteria:

- Subjects > 30 years of age

- Subjects who are ambulatory not requiring assistance for ambulation

- Subjects who have been informed of the nature of the study and agree to its
provisions and have provided written informed consent as approved by the IRB

Exclusion Criteria:

- Subjects with an active implantable medical device not cleared for use with the
IMED-4 in the IMED- 4 Investigators Brochure.

- Subjects who are pregnant or lactating or who have been pregnant within the past
three months

- Subjects who have a measured temperature of >38° C at the time of screening

- Subjects who have tattoos and/or non-intact skin on the back in the electrode patch
placement region

- Subjects who have had a past serious allergic reaction to adhesives

- Patients who decline to have their backs photographed with the IMED-4 device in
position

- Subjects who have poor general physical/mental health that, in the opinion of the
investigator, will not allow the subject to be a good study candidate (i.e. other
disease processes, mental capacity, substance abuse, incarceration, shortened life
expectance, etc.)
We found this trial at
1
site
Intersection Medical Inc.
Carlsbad, California 92008
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mi
from
Carlsbad, CA
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