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OpenTrials
Completed

NCT Number: NCT02426593

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

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.

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Key information

Conditions

Healthy Cardiovascular Diseases Heart Diseases Heart Failure

Age range

30 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Intersection Medical Inc.

Carlsbad, California, 92008, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.)

Treatment and study plan

IMED-4

Device

Non-invasive novel lung hydration status sensor.

Primary outcomes

  1. Data Collection

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Intersection Medical, Inc.

Industry

Registry information

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Apr 27, 2015
Registry last updated
Oct 14, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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