Expired Study
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Carlsbad, California 92008


Purpose:

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.


Criteria:

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 is Available At:


Original ID:

CP-000060


NCT ID:

NCT02426593


Secondary ID:


Study Acronym:


Brief Title:

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


Official Title:

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


Overall Status:

Completed


Study Phase:

N/A


Genders:

Both


Minimum Age:

30 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Intersection Medical, Inc.


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Observational


Study Design:

Observational Model: Ecologic or Community, Time P


Number of Arms:

0


Number of Groups:

1


Total Enrollment:

100


Enrollment Type:

Anticipated


Study Dates

Start Date:April 2015
Completion Date:September 2015
Completion Type:Actual
Primary Completion Date:September 2015
Primary Completion Type:Actual
Verification Date:October 2015
Last Changed Date:October 13, 2015
First Received Date:April 22, 2015

Study Outcomes

Outcome Type:Primary Outcome
Measure:Data Collection
Time Frame:12 months
Safety Issues:False
Description: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.

Study Interventions

Intervention Type:Device
Name:IMED-4
Description:Non-invasive novel lung hydration status sensor.
Arm Name:Subjects without heart failure

Study Arms

Study Arm Type:Other
Arm Name:Subjects without heart failure

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Intersection Medical, Inc.

Samples and Retentions

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.
Sample Method:Non-Probability Sample

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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