Ignite Creation Date:
2025-12-25 @ 1:11 AM
Ignite Modification Date:
2026-01-22 @ 2:20 AM
Study NCT ID:
NCT02426593
Status:
COMPLETED
Last Update Posted:
2015-10-14
First Post:
2015-04-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Collection of Anatomical and Reference Data for Development of a Novel Non-Invasive Lung Hydration Status Technology
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'ECOLOGIC_OR_COMMUNITY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-10', 'completionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-10-13', 'studyFirstSubmitDate': '2015-04-22', 'studyFirstSubmitQcDate': '2015-04-24', 'lastUpdatePostDateStruct': {'date': '2015-10-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-04-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Data Collection', 'timeFrame': '12 months', '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.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['CHF', 'Heart Failure'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '30 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects \\> 30 years of age\n* Subjects who are ambulatory not requiring assistance for ambulation\n* 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\n\nExclusion Criteria:\n\n* Subjects with an active implantable medical device not cleared for use with the IMED-4 in the IMED- 4 Investigators Brochure.\n* Subjects who are pregnant or lactating or who have been pregnant within the past three months\n* Subjects who have a measured temperature of \\>38° C at the time of screening\n* Subjects who have tattoos and/or non-intact skin on the back in the electrode patch placement region\n* Subjects who have had a past serious allergic reaction to adhesives\n* Patients who decline to have their backs photographed with the IMED-4 device in position\n* 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.)'}, 'identificationModule': {'nctId': 'NCT02426593', 'briefTitle': 'Collection of Anatomical and Reference Data for Development of a Novel Non-Invasive Lung Hydration Status Technology', 'organization': {'class': 'INDUSTRY', 'fullName': 'Intersection Medical, Inc.'}, 'officialTitle': 'Collection of Anatomical and Reference Data for Development of a Novel Non-Invasive Lung Hydration Status Technology', 'orgStudyIdInfo': {'id': 'CP-000060'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Subjects without heart failure', 'interventionNames': ['Device: IMED-4']}], 'interventions': [{'name': 'IMED-4', 'type': 'DEVICE', 'description': 'Non-invasive novel lung hydration status sensor.', 'armGroupLabels': ['Subjects without heart failure']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92008', 'city': 'Carlsbad', 'state': 'California', 'country': 'United States', 'facility': 'Intersection Medical Inc.', 'geoPoint': {'lat': 33.15809, 'lon': -117.35059}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Intersection Medical, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}