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

Intersection Medical

Status: Completed

Conditions: Healthy

Treatments: Device: IMED-4

Study type: Observational

Funder types: Industry

Identifiers

NCT02426593

CP-000060

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 30+ years old

Volunteers: Accepts Healthy Volunteers

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.)

Trial design

100 participants in 1 patient group

Subjects without heart failure

Treatment:

Device: IMED-4