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

NCT02426593 | Completed

• 1 other identifier: CP-000060
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy

Keywords

CHF; Heart Failure

Outcome Measures

Primary Outcomes (1)

• Data Collection

  The primary endpoint is successful IMED-4 recordings at multiple timepoints from one hundred (100) unique subjects. A recording will be considered successful if it meets IMED-4 recording quality indicators.

  12 months

Study Arms (1)

Subjects without heart failure

Device: IMED-4

Interventions

IMED-4 DEVICE

Non-invasive novel lung hydration status sensor.

Subjects without heart failure

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects will be recruited from the general population using various media advertising as well as through a site database. Potential subjects aged older than 30 will be recruited for a telephone interview. If they qualify based on a very brief screening interview regarding their suitability as a participant, and they are interested in participating, they will be scheduled to visit the Intersection Medical, Inc., corporate office. If they decline to participate, no further contact will be initiated.

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.)

Sponsors & Collaborators

• Intersection Medical, Inc.: lead

Study Sites (1)

Intersection Medical Inc.

Carlsbad, California, 92008, United States

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2015
• First Posted: April 27, 2015
• Study Start: April 1, 2015
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: October 14, 2015

Record last verified: 2015-10

Locations

US (1)