Ignite Creation Date:
2025-12-25 @ 2:42 AM
Ignite Modification Date:
2026-02-24 @ 11:39 AM
Study NCT ID:
NCT02856633
Status:
COMPLETED
Last Update Posted:
2017-05-09
First Post:
2016-07-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Preliminary Testing of the Vitaliti CVSM Wearable, Vitaliti Spirotoscope, and Vitaliti IVD Station
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014552', 'term': 'Urinary Tract Infections'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D001281', 'term': 'Atrial Fibrillation'}, {'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D010033', 'term': 'Otitis Media'}, {'id': 'D007964', 'term': 'Leukocytosis'}, {'id': 'D006973', 'term': 'Hypertension'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D010031', 'term': 'Otitis'}, {'id': 'D004427', 'term': 'Ear Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D007960', 'term': 'Leukocyte Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2017-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-08', 'studyFirstSubmitDate': '2016-07-29', 'studyFirstSubmitQcDate': '2016-08-02', 'lastUpdatePostDateStruct': {'date': '2017-05-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-08-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-02-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Successful diagnosis of patient's condition by Vitaliti software as compared to patient's Medical Record", 'timeFrame': '90 minutes'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Urinary Tract Infection', 'Diabetes Mellitus', 'Atrial Fibrillation', 'OSA', 'COPD', 'Pneumonia', 'Acute Otitis Media', 'Leukocytosis', 'Iron Deficient Anemia', 'Hypertension', 'Healthy Volunteers']}, 'descriptionModule': {'briefSummary': "The study objective is to satisfy the testing requirements for the Qualcomm Tricorder XPRIZE Competition. This requires an oversight model using the Vitaliti CVSM Wearable, Vitaliti Spirotoscope, and Vitaliti IVD Station to continuously monitor the patient's five core vital signs and to detect the health conditions required by the competition."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Adult subjects with urinary tract infection, diabetes mellitus, atrial fibrillation, sleep apnea, COPD, pneumonia, acute otitis media, leukocytosis, anemia, or hypertension will be recruited to participate in this observational study from Oakville-Trafalgar Memorial Hospital.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 to 65 years of age.\n* English speaking\n* Established diagnosis of one of the thirteen required conditions with evidence in Medical Record.\n\nExclusion Criteria:\n\n* Lack of patient consent\n* Has pacemaker or internal medical device\n* Pregnancy\n* Concurrent enrollment into a clinical trial that may affect subject treatment\n* Age less than 18 or over 65\n* Physical disabilities affecting vision (eyeglasses or contact lenses will be allowed), manual manipulation, or use of a computer or mobile device'}, 'identificationModule': {'nctId': 'NCT02856633', 'briefTitle': 'Preliminary Testing of the Vitaliti CVSM Wearable, Vitaliti Spirotoscope, and Vitaliti IVD Station', 'organization': {'class': 'INDUSTRY', 'fullName': 'Cloud DX Inc.'}, 'officialTitle': 'Preliminary Testing of the Vitaliti CVSM Wearable, Vitaliti Spirotoscope, and Vitaliti IVD Station', 'orgStudyIdInfo': {'id': 'STP-VIT-001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Vitaliti System', 'interventionNames': ['Device: Vitaliti']}], 'interventions': [{'name': 'Vitaliti', 'type': 'DEVICE', 'armGroupLabels': ['Vitaliti System']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'L6M 0L8', 'city': 'Oakville', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Oakville Trafalgar Memorial Hospital', 'geoPoint': {'lat': 43.45011, 'lon': -79.68292}}], 'overallOfficials': [{'name': 'Sonny Kohli, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Oakville Trafalgar Memorial Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cloud DX Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}