Ignite Creation Date:
2025-12-24 @ 11:50 AM
Ignite Modification Date:
2026-01-03 @ 9:32 PM
Study NCT ID:
NCT03409861
Status:
UNKNOWN
Last Update Posted:
2018-01-24
First Post:
2018-01-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
'Wristband Device for the Measurement of Intermittent Blood Pressure and Other Physiological Signals
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2018-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2018-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-01-23', 'studyFirstSubmitDate': '2018-01-03', 'studyFirstSubmitQcDate': '2018-01-23', 'lastUpdatePostDateStruct': {'date': '2018-01-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-01-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Blood Pressure Monitoring', 'timeFrame': '30-60 seconds of a clean signal from the A-line monitor', 'description': 'Wearing of a non invasive wristband to measure Blood Pressure'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Blood Pressure']}, 'descriptionModule': {'briefSummary': 'A wristband device intended for use as a standalone device, designed for the measurement of intermittent blood pressure, as well as other physiological signals. The device is intended to be worn in day to day life by individuals suffering from hypertension or other conditions where monitoring of blood pressure is of importance.', 'detailedDescription': 'The device is intended to be worn on the wrist for intermittent measurements of vital signs such as HR, blood pressure, Skin temperature and activity.\n\nThe use does not require any special action from the user apart form wearing the band on either their left or right wrist. The device applies no inflatable mechanics or moving parts. The waistband is watertight and can be worn as any type of bracelet all the time of most of the time.\n\nThe study will focus on patients in intensive care or any other cardiology unit who are under continuous oversight of existing Invasive (A-line Gold Standard monitors'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Male and females over the age of 18 years Patients who are already fitted with and invasive Arterial Line (A-Line)', 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Signed written Institution approved Informed Consent Form (ICF)\n2. Male and Females over the age of 18 years\n3. Patients in intensive care or cardiology units who are under continuous oversight of existing Invasive (A-Line) Gold Standard monitors.\n4. Only subjects who are fitted with an invasive Arterial Line (A LINE)\n5. To the extent possible, individuals who have not been using medication 5 (five) hours prior to the test shall be classified as non-medicated subjects.\n\nExclusion Criteria:\n\n1. Subject who are unable to provide consent\n2. Where it would be impractical or inconvenient or otherwise unfeasible to place to place a wristband and generate a signal.\n3. Subjects who are not fitted with, or not planned to be fitted with an A-Line during their stay in the hospital.'}, 'identificationModule': {'nctId': 'NCT03409861', 'briefTitle': "'Wristband Device for the Measurement of Intermittent Blood Pressure and Other Physiological Signals", 'organization': {'class': 'OTHER_GOV', 'fullName': 'Hillel Yaffe Medical Center'}, 'officialTitle': 'Non-invasive, Non-Oscillometric Blood Pressure Band', 'orgStudyIdInfo': {'id': 'GuardLyff'}}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Michal Binebaum', 'role': 'CONTACT', 'email': 'michal.binenbaum@guardlyff.com', 'phone': '972(0)547299564'}], 'overallOfficials': [{'name': 'Avraham Shotan, Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Principal Investigator'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hillel Yaffe Medical Center', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}