Ignite Creation Date:
2025-12-24 @ 10:54 PM
Ignite Modification Date:
2026-02-26 @ 12:20 AM
Study NCT ID:
NCT03837769
Status:
COMPLETED
Last Update Posted:
2019-06-03
First Post:
2019-02-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Validation of the Aktiia SA PulseWatch OBPM Device at the Wrist Against Invasive Blood Pressure Measurements
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 31}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-02-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-05', 'completionDateStruct': {'date': '2019-05-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-05-31', 'studyFirstSubmitDate': '2019-02-06', 'studyFirstSubmitQcDate': '2019-02-08', 'lastUpdatePostDateStruct': {'date': '2019-06-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-02-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-05-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cuffless Blood Pressure performance', 'timeFrame': '4 Months', 'description': 'The evaluation of the accuracy (mean error and standard deviation of the error) of the non-invasive BP measurements at wrist with the PulseWatch against the reference gold-standard invasive blood pressure obtained by arterial line with respect to ISO 81060-2 (14) for two aspects: i) capturing the variations of the BP in short time and ii) maintaining the accurate stable measurements over extended periods of time.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Blood Pressure', 'OBPM', 'Cuffless'], 'conditions': ['Blood Pressure']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.aktiia.com', 'label': 'Aktiia SA website'}]}, 'descriptionModule': {'briefSummary': 'Single-centre intervention study to validate the performance of the Aktiia SA optical blood pressure monitoring (OBPM) device at the wrist against invasive blood pressure measurements with arterial line.', 'detailedDescription': 'Aktiia SA PulseWatch is an investigational device for the optical measurement of blood pressure that uses only optical sensors at the wrist. HNE is interested in exploring the potential of the device and technology (OBPM), and aims at benchmarking its performances against gold standard measurements of blood pressure.\n\nThe goal of this study is thus to assess whether i) PulseWatch allows to capture blood pressure variations, and ii) the measured blood pressure values remain stable in time.\n\nThe proposed study plans to include patients that are already scheduled for arterial catheterization at HNE. For these patients, the study will only require the placement of the safe optical device on the wrist to non-invasively record hemodynamic fluctuations. Therefore, no additional risk for the patient is to be foreseen.\n\nBy demonstrating that the Aktiia SA OBPM technology is reliable, HNE aims to make one step further in improving blood pressure monitoring in general, and in particular in advancing the deployment of technologies that have the potential to be used in the ambulatory setting. The diagnosis and treatment of hypertension are expected to largely benefit from these advancements.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Age ≥ 18 years\n* No significant non-invasive systolic blood pressure difference between left arm and right arm (difference \\<20mmHg in systolic arterial pressure)\n* Patient requires continuous monitoring of diastolic and systolic blood pressure continuously via a radial arterial line;\n* Patient information and informed consent is obtained following the procedures described in CIP\n\nExclusion criteria:\n\n* Arrythmias: tachycardia (resting heart rate \\> 120/min) at time of study inclusion\n* Atrial fibrillation\n* Psychomotor agitation\n* Significant bruises or trauma on forearm\n* Intravenous canula around the wrist with impossibility to place the device (Aktiia OBPM PulseWatch) around the wrist'}, 'identificationModule': {'nctId': 'NCT03837769', 'acronym': 'OBPM_ICU2018', 'briefTitle': 'Validation of the Aktiia SA PulseWatch OBPM Device at the Wrist Against Invasive Blood Pressure Measurements', 'organization': {'class': 'OTHER', 'fullName': 'Hopital Neuchatelois'}, 'officialTitle': 'Single-center Intervention Study to Validate the Performance of the Aktiia SA PulseWatch Optical Blood Pressure Monitoring (OBPM) Device at the Wrist Against Invasive Blood Pressure Measurements With Arterial Line', 'orgStudyIdInfo': {'id': 'OBPM_ICU2018'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Aktiia SA PulseWatch', 'description': 'Aktiia OBPM PulseWatch wrist device', 'interventionNames': ['Device: Aktiia OBPM PulseWatch wrist device']}], 'interventions': [{'name': 'Aktiia OBPM PulseWatch wrist device', 'type': 'DEVICE', 'description': 'The optical signals at the wrist are recorded non-invasively. The BP measurements are further determined from these optical signals and are compared to the reference BP readings.', 'armGroupLabels': ['Aktiia SA PulseWatch']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2000', 'city': 'Neuchâtel', 'country': 'Switzerland', 'facility': 'Hôpital neuchâtelois - Pourtalès', 'geoPoint': {'lat': 46.99179, 'lon': 6.931}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hopital Neuchatelois', 'class': 'OTHER'}, 'collaborators': [{'name': 'Aktiia SA', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}