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

Completed

• Conditions: Healthy
• Interventions: Device: IMED-4

• Registration Number: NCT02426593
• Lead Sponsor: Intersection Medical, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-04
• Study First Submitted: 2015-04-22
• Study First Submitted QC: 2015-04-24
• Study First Posted: 2015-04-27
• Primary Completion: 2015-09
• Study Completion: 2015-09
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-13
• Last Update Posted: 2015-10-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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.)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Subjects without heart failure	IMED-4	-

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Intersection Medical Inc.; 🇺🇸 Carlsbad, California, United States