Collection of Anatomical and Reference Data for Development of a Novel Non-Invasive Lung Hydration Status Technology
Completed
Conditions studied: Healthy
In brief
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.
Key facts
- Study ID
- NCT02426593
- Run by
- Intersection Medical, Inc.
- People needed
- 100
- Starts
- 2015-04-01
- Expected to finish
- 2015-09-01
- Last updated by the study team
- 2015-10-14
Who can join
Age: 30 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.)
Where it is running
- Intersection Medical Inc. — Carlsbad, California, United States
Full record on ClinicalTrials.gov
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