Ignite Creation Date:
2025-12-26 @ 10:59 AM
Ignite Modification Date:
2025-12-29 @ 4:46 PM
Study NCT ID:
NCT06368206
Status:
RECRUITING
Last Update Posted:
2024-12-17
First Post:
2024-04-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Recording of Physiological Data Via an Optical Sensor At the Fingertip Alongside with Double Auscultatory and Pulse Oximetry to Evaluate the Effectiveness of an Optical Blood Pressure Monitoring (OBPM)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001794', 'term': 'Blood Pressure'}], 'ancestors': [{'id': 'D055986', 'term': 'Vital Signs'}, {'id': 'D010808', 'term': 'Physical Examination'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D006439', 'term': 'Hemodynamics'}, {'id': 'D002320', 'term': 'Cardiovascular Physiological Phenomena'}, {'id': 'D002943', 'term': 'Circulatory and Respiratory Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': '1 study cohort that will test investigational device (Aktiia G2C) and Blood Pressure and Pulse Rate references.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 85}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-06-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-12', 'studyFirstSubmitDate': '2024-04-04', 'studyFirstSubmitQcDate': '2024-04-11', 'lastUpdatePostDateStruct': {'date': '2024-12-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of study subjects that contribute with analyzable raw data collected', 'timeFrame': '1 hour', 'description': 'Min 85 study subjects contribute with analyzable raw data collected'}], 'secondaryOutcomes': [{'measure': 'Blood pressure mean value of differences', 'timeFrame': '1 hour', 'description': 'The mean value of the differences between Aktiia G2C and double auscultation blood pressure measurements.'}, {'measure': 'Blood pressure standard deviation of differences', 'timeFrame': '1 hour', 'description': 'The mean value of the differences between Aktiia G2C and double auscultation blood pressure measurements.'}, {'measure': 'Pulse rate root-mean-square error', 'timeFrame': '1 hour', 'description': 'The root-mean-square difference between the Aktiia G2C pulse rate determinations and the reference method.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hypertension']}, 'descriptionModule': {'briefSummary': 'The present study, OBPM\\_Calfree2024, with N = 85 participants minimum over 1 visit (lasting around 1h), has been designed to collect raw optical data with Aktiia.product-G2C Clinical investigational system together with several reference systems within a cohort of subjects characterized by a wide variety of phenotypes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Subjects aged 21 to 85yo\n* Subjects fluent in written and spoken French\n* Subjects agreeing to attend the study visit and follow study procedures\n* Subjects that have signed the informed consent form.\n\nExclusion Criteria:\n\n* Amputated index fingers\n* Damaged/injured skin at index fingers\n* Damaged/injured skin at wrists\n* Subjects suffering from sustained cardiac arrhythmias that can lead to weak or unstable pressure pulses including tachycardia (heart rate at rest \\> 120bpm) and atrial fibrillation\n* Subjects suffering from pathologies that systematically reduce peripheral perfusion including Raynaud's disease, diabetes, renal dysfunctions (eGFR \\< 30mL/min/1.73 m2), hyper-/hypothyroidism, pheochromocytoma or arteriovenous fistula\n* Pregnant women\n* Polyneuropathy"}, 'identificationModule': {'nctId': 'NCT06368206', 'briefTitle': 'Recording of Physiological Data Via an Optical Sensor At the Fingertip Alongside with Double Auscultatory and Pulse Oximetry to Evaluate the Effectiveness of an Optical Blood Pressure Monitoring (OBPM)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Aktiia SA'}, 'officialTitle': 'Recording of Physiological Data Via an Optical Sensor At the Fingertip Alongside with Double Auscultatory and Pulse Oximetry to Evaluate the Effectiveness of an Optical Blood Pressure Monitoring (OBPM) Algorithm That Requires No Calibration with an External Cuff: a Single-center Prospective Clinical Study', 'orgStudyIdInfo': {'id': 'OBPM_Calfree2024'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Aktiia G2C and references/ comparators for Blood Pressure and Pulse Rate monitoring', 'description': 'All study participants will test the investigational device (Aktiia G2C) and other marketed devices for blood pressure and pulse rate measurements (Aktiia Bracelet G2, Double auscultation, oscillometric monitors, finger pulse oximeter).', 'interventionNames': ['Device: Investigational device Aktiia G2C', 'Device: Marketed device used as reference for blood pressure monitoring: double auscultation cuff', 'Device: Marketed device used as comparative device for blood pressure and pulse rate monitoring: Aktiia Bracelet G2', 'Device: Marketed device used as comparative device for blood pressure and pulse rate monitoring: oscillometric upper-arm cuff', 'Device: Marketed device used as comparative device for blood pressure and pulse rate monitoring: oscillometric wrist cuff', 'Device: Marketed device used as reference for pulse rate monitoring: pulse finger oximeter']}], 'interventions': [{'name': 'Investigational device Aktiia G2C', 'type': 'DEVICE', 'description': 'Study subjects are asked to stay seated and relaxed while successive measurements are taken with Aktiia G2C.', 'armGroupLabels': ['Aktiia G2C and references/ comparators for Blood Pressure and Pulse Rate monitoring']}, {'name': 'Marketed device used as reference for blood pressure monitoring: double auscultation cuff', 'type': 'DEVICE', 'description': 'Study subjects are asked to stay seated and relaxed while successive measurements are taken with cuff for double auscultation.', 'armGroupLabels': ['Aktiia G2C and references/ comparators for Blood Pressure and Pulse Rate monitoring']}, {'name': 'Marketed device used as comparative device for blood pressure and pulse rate monitoring: Aktiia Bracelet G2', 'type': 'DEVICE', 'description': 'Study subjects are asked to stay seated and relaxed while successive measurements are taken with Aktiia Bracelet G2.', 'armGroupLabels': ['Aktiia G2C and references/ comparators for Blood Pressure and Pulse Rate monitoring']}, {'name': 'Marketed device used as comparative device for blood pressure and pulse rate monitoring: oscillometric upper-arm cuff', 'type': 'DEVICE', 'description': 'Study subjects are asked to stay seated and relaxed while taking successive measurements with an oscillometric upper-arm cuff.', 'armGroupLabels': ['Aktiia G2C and references/ comparators for Blood Pressure and Pulse Rate monitoring']}, {'name': 'Marketed device used as comparative device for blood pressure and pulse rate monitoring: oscillometric wrist cuff', 'type': 'DEVICE', 'description': 'Study subjects are asked to stay seated and relaxed while taking successive measurements with an oscillometric wrist cuff.', 'armGroupLabels': ['Aktiia G2C and references/ comparators for Blood Pressure and Pulse Rate monitoring']}, {'name': 'Marketed device used as reference for pulse rate monitoring: pulse finger oximeter', 'type': 'DEVICE', 'description': 'Study subjects are asked to stay seated and relaxed while successive measurements are taken with pulse finger oximeter.', 'armGroupLabels': ['Aktiia G2C and references/ comparators for Blood Pressure and Pulse Rate monitoring']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1011', 'city': 'Lausanne', 'status': 'RECRUITING', 'country': 'Switzerland', 'contacts': [{'name': 'Grégoire Wuerzner, MD Prof', 'role': 'CONTACT', 'email': 'gregoire.wuerzner@chuv.ch', 'phone': '+41213141131'}], 'facility': 'CHUV', 'geoPoint': {'lat': 46.516, 'lon': 6.63282}}], 'centralContacts': [{'name': 'Grégoire Wuerzner, Medical Doctor Prof.', 'role': 'CONTACT', 'email': 'gregoire.wuerzner@chuv.ch', 'phone': '+41213140223'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aktiia SA', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}