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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02426593

Enrollment

100

Registered

2015-04-27

Start date

2015-04-30

Completion date

2015-09-30

Last updated

2015-10-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

CHF, Heart Failure

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.

Interventions

DEVICEIMED-4

Non-invasive novel lung hydration status sensor.

Study design

Observational model

ECOLOGIC_OR_COMMUNITY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

30 Years to No maximum

Healthy volunteers

Yes

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.)

Design outcomes

Primary

Measure	Time frame	Description
Data Collection	12 months	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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026