Ignite Creation Date:
2025-12-26 @ 4:03 PM
Ignite Modification Date:
2026-02-24 @ 4:11 AM
Study NCT ID:
NCT02570906
Status:
COMPLETED
Last Update Posted:
2016-02-26
First Post:
2015-09-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Performance Assessment of a Remote Patient Monitoring Device
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-02', 'completionDateStruct': {'date': '2016-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-02-25', 'studyFirstSubmitDate': '2015-09-01', 'studyFirstSubmitQcDate': '2015-10-05', 'lastUpdatePostDateStruct': {'date': '2016-02-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-10-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Heart rate accuracy', 'timeFrame': 'On the day of enrollment to completion of one-time study visit', 'description': 'No follow-up visits will occur'}, {'measure': 'Heart rate precision', 'timeFrame': 'On the day of enrollment to completion of one-time study visit', 'description': 'No follow-up visits will occur'}, {'measure': 'Respiratory rate accuracy', 'timeFrame': 'On the day of enrollment to completion of one-time study visit', 'description': 'No follow-up visits will occur'}, {'measure': 'Respiratory rate precision', 'timeFrame': 'On the day of enrollment to completion of one-time study visit', 'description': 'No follow-up visits will occur'}, {'measure': 'Activity', 'timeFrame': 'On the day of enrollment to completion of one-time study visit', 'description': 'Activity will be classified as lying, upright, walking, or running.'}, {'measure': 'Body orientation (position)', 'timeFrame': 'On the day of enrollment to completion of one-time study visit', 'description': 'Body orientation (position) if lying horizontally will be classified as facing right, facing left, facing down (prone), or facing up (supine).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Physiologic Monitoring']}, 'descriptionModule': {'briefSummary': 'This study will evaluate the performance of the Zephyr BioPatch in measuring heart rate, respiration rate, posture, and activity level compared to reference devices in healthy adult subjects during a variety of situations including hospital room movements, talking, and a short bout of exercise.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Healthy Volunteers, Adults 18 to 50 years old', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Signed and dated informed consent by subject or legally authorized representative (LAR)\n2. Male or female of any race\n3. 18-50 years of age, inclusive\n4. Willingness to have study devices attached during study participation\n5. Willingness to participate in all aspects of the study\n6. Ability to walk without human assistance or walking aides (e.g. cane or walker), in the opinion of the investigator\n\nExclusion Criteria:\n\n1. Subject is unable to provide informed consent\n2. Under 18 years of age or over 50 years of age\n3. Implanted pacemaker or defibrillator\n4. Diagnosis of atrial fibrillation as reported by the subject\n5. Current hospital admission\n6. History of hospital admission or a surgical procedure in the 60 days prior to study enrollment\n7. Any contraindications to protocol specific repositioning techniques (e.g. turning on right side or left side or lying in supine position)\n8. Female subject is pregnant and/or lactating as reported by the subject\n9. Subject is considered as being morbidly obese (defined as BMI \\>39.5)\n10. Subject is on any medications, in the opinion of the investigator, that would impair heart response during the short bout of exercise\n11. A serious concurrent medical or other condition, in the opinion of the investigator, that would impair protocol compliance or safety of the subject'}, 'identificationModule': {'nctId': 'NCT02570906', 'briefTitle': 'Performance Assessment of a Remote Patient Monitoring Device', 'nctIdAliases': ['NCT02606968'], 'organization': {'class': 'INDUSTRY', 'fullName': 'Medtronic - MITG'}, 'officialTitle': 'A Performance Assessment of a Remote Patient Monitoring Device in Measuring Heart Rate, Respiration Rate, Posture, and Activity Level', 'orgStudyIdInfo': {'id': 'COVMOPO0517'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Zephyr BioPatch', 'type': 'DEVICE', 'description': 'Remote patient monitoring devices: BioPatch™ (ZephyrLIFE Hospital System™)'}]}, 'contactsLocationsModule': {'locations': [{'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Columbia University Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'William Whang, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Columbia University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medtronic - MITG', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}