Ignite Creation Date:
2025-12-25 @ 2:53 AM
Ignite Modification Date:
2025-12-31 @ 8:48 AM
Study NCT ID:
NCT01196533
Status:
COMPLETED
Last Update Posted:
2019-01-31
First Post:
2010-08-29
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Comparative Clinical Trial of the TensorTip, a Novel Non Invasive Device for Measurement Blood Parameters
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000740', 'term': 'Anemia'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D007022', 'term': 'Hypotension'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}], 'ancestors': [{'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'frank.smart@atlantichealth.org', 'phone': '973-214-2601', 'title': 'Dr. Frank Smart', 'organization': 'Morristowm Memorial Hospital'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Non Invasive Monitoring', 'description': 'single group of hospitalized cardiovascular patients', 'otherNumAtRisk': 94, 'otherNumAffected': 0, 'seriousNumAtRisk': 94, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Comparison of the TensorTip Accuracy Against Hospital Periodical Readings.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Non Invasive Monitoring', 'description': 'single group of hospitalized cardiovascular patients'}], 'classes': [{'title': 'pulse', 'categories': [{'measurements': [{'value': '0.6', 'groupId': 'OG000'}]}]}, {'title': 'Blood Pressure-systolic', 'categories': [{'measurements': [{'value': '7.9', 'groupId': 'OG000'}]}]}, {'title': 'Blood Pressure-diastolic', 'categories': [{'measurements': [{'value': '7.5', 'groupId': 'OG000'}]}]}, {'title': 'Spo2', 'categories': [{'measurements': [{'value': '2.33', 'groupId': 'OG000'}]}]}, {'title': 'PO2', 'categories': [{'measurements': [{'value': '5.99', 'groupId': 'OG000'}]}]}, {'title': 'PCO2', 'categories': [{'measurements': [{'value': '5.3', 'groupId': 'OG000'}]}]}, {'title': 'MAP', 'categories': [{'measurements': [{'value': '6.67', 'groupId': 'OG000'}]}]}, {'title': 'Hemoglobin', 'categories': [{'measurements': [{'value': '8.9', 'groupId': 'OG000'}]}]}, {'title': 'cardiac output', 'categories': [{'measurements': [{'value': '26.9', 'groupId': 'OG000'}]}]}, {'title': 'Hematocrit', 'categories': [{'measurements': [{'value': '3.8', 'groupId': 'OG000'}]}]}, {'title': 'RBC', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'O2', 'categories': [{'measurements': [{'value': '1.15', 'groupId': 'OG000'}]}]}, {'title': 'CO2', 'categories': [{'measurements': [{'value': '4.75', 'groupId': 'OG000'}]}]}, {'title': 'Stroke volume', 'categories': [{'measurements': [{'value': '26.9', 'groupId': 'OG000'}]}]}, {'title': 'pH', 'categories': [{'measurements': [{'value': '0.03', 'groupId': 'OG000'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'otherAnalysisDescription': 'All data in the outcome measure table is presenting the percentage of error.'}], 'paramType': 'NUMBER', 'timeFrame': 'one year', 'description': 'To validate the parameters with similar measures obtained with standard invasive techniques in hospitalized patients.\n\nMethodology:\n\nEligible real time color signal obtained by the TensorTip shall be recorded simultaneously during the monitoring performed.\n\nAn algorithm shall be designed according to the blood color distribution to each parameter and a final test shall be recorded signals.\n\nStatistical analysis for each parameter shall perform on the entire eligible recorded signals.\n\nDetermination of Accuracy:\n\nErr = √(1/N ∑N (Ref(k)-NewDevice(k)) \\^2 ) (k=1)\n\nFor each parameter a satisfactory result is considered when Err satisfies the industry requirement.\n\nResults viewing Each parameter comparative study shall be presented on a (X,Y) plan versus a regression line where X - represents the results measured by TensorTip and Y - the reference results.', 'unitOfMeasure': 'percentage of error', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Non Invasive Monitoring', 'description': 'Single group of hospitalized cardiovascular patients.\n\nNon invasive peripheral blood monitoring: non invasive monitoring'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '94'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '94'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'during 2009'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Non Invasive Monitoring', 'description': 'single group of hospitalized cardiovascular patients'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '51.5', 'groupId': 'BG000', 'lowerLimit': '18', 'upperLimit': '85'}]}]}], 'paramType': 'MEAN', 'description': '18 years and older', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'number of participants', 'categories': [{'measurements': [{'value': '94', 'groupId': 'BG000'}]}]}, {'title': 'Male', 'categories': [{'measurements': [{'value': '45', 'groupId': 'BG000'}]}]}, {'title': 'Female', 'categories': [{'measurements': [{'value': '49', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '94', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 94}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-01-30', 'studyFirstSubmitDate': '2010-08-29', 'resultsFirstSubmitDate': '2016-01-21', 'studyFirstSubmitQcDate': '2010-09-04', 'lastUpdatePostDateStruct': {'date': '2019-01-31', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-01-30', 'studyFirstPostDateStruct': {'date': '2010-09-08', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-01-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2013-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparison of the TensorTip Accuracy Against Hospital Periodical Readings.', 'timeFrame': 'one year', 'description': 'To validate the parameters with similar measures obtained with standard invasive techniques in hospitalized patients.\n\nMethodology:\n\nEligible real time color signal obtained by the TensorTip shall be recorded simultaneously during the monitoring performed.\n\nAn algorithm shall be designed according to the blood color distribution to each parameter and a final test shall be recorded signals.\n\nStatistical analysis for each parameter shall perform on the entire eligible recorded signals.\n\nDetermination of Accuracy:\n\nErr = √(1/N ∑N (Ref(k)-NewDevice(k)) \\^2 ) (k=1)\n\nFor each parameter a satisfactory result is considered when Err satisfies the industry requirement.\n\nResults viewing Each parameter comparative study shall be presented on a (X,Y) plan versus a regression line where X - represents the results measured by TensorTip and Y - the reference results.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Anemia', 'Diabetes', 'Heart Disease', 'High Blood Pressure', 'Hypotension', 'Metabolic Diseases', 'Respiratory Diseases']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.cnoga.com', 'label': 'Sponsor website.'}]}, 'descriptionModule': {'briefSummary': '1. Aim:\n\n The aim of the clinical trial is to study the accuracy of the TensorTip device compared with registered (FDA-approved) invasive and non-invasive devices.\n2. Hypothesis:\n\nHuman physiological biomarkers may be measured from the color distribution of the internal or external (skin) tissue. The technology of the TensorTip finger-mounted device is based on the color distribution of the peripheral blood tissue, which enables the measurement of certain biomarkers and vital signs under consideration.', 'detailedDescription': 'The TensorTip (previously named Soft Touch) is a novel non invasive Finger tip device that. The Tensor Tip is a non-invasive device which was designed and aimed to measure a wide range of physiological and bio-parameters such as blood glucose, hemoglobin and hematocrit, blood PH, oxygen saturation SpO2, blood carbon dioxide, blood pressure, peripheral pulse and more based on the temporarily color distribution of the tissue under consideration. The Tensor Tip is based on real time color image sensor, real time photographing the fingertip tissue. A color image sensor of the type used in the Tensor Tip enables a wide range of information in the spectral, resolution, dynamic range and time domains enabling further investigation of the blood chromatic changes as a function body physiology. The concept behind this investigation reflects the idea that a change in human physiology condition would temporarily change the blood pigmentation.\n\nThe present study is aimed to assess the accuracy of the novel device in measuring all the above mentioned parameters by recording AS IS the change of the fingertip color tissue while simultaneous recording the standard invasive measured parameters on daily or periodic routine in the hospitalized patients.\n\nThis vast data recordings (tissue and references) enable the Tensor tip to analyze a particular bio parameter. The tensor tip is calibrated to a certain bio parameter based on the vast data set collected.\n\nThe bio parameter under consideration are: Arterial Systolic and Diastolic, MAP, PA systolic, PA Diastolic, CO, Heart rate, Stroke volume, WBC, RBC, Hgb, HCT ,Iron, PLT, PH, PCO2, PO2, HCO3, SaO2 , Na, K, Cl, CO2, Bun, Cr, Gluc, HGB (A1C),TBiLi, LDL, HDL.\n\nThis study hopes to demonstrate the connection between blood color pigmentation and certain bio parameters for simplifying monitoring procedure and particular home monitoring.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Male or female, age \\> 18\n2. Patients with cardiovascular disease and/or with diabetes mellitus type I or II and/or with COPD.\n3. Patients receiving coronary artery bypass with or without valve repair.\n4. Able to sign an informed consent.\n\nExclusion Criteria:\n\n1. Refusal to sign an informed consent and to participate in the study.\n2. Participant plans to enroll in another other clinical trial of an investigational agent while participating in this study.\n3. Below the age of 18.'}, 'identificationModule': {'nctId': 'NCT01196533', 'briefTitle': 'A Comparative Clinical Trial of the TensorTip, a Novel Non Invasive Device for Measurement Blood Parameters', 'organization': {'class': 'INDUSTRY', 'fullName': 'Cnoga Medical Ltd.'}, 'officialTitle': 'A Comparative Clinical Trial to Assess the Accuracy of the TensorTip, a Novel Non Invasive Device for the Measurement of Physiological and Blood Chemistry Parameters', 'orgStudyIdInfo': {'id': 'CMIL-MHUS-V1.0'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Non Invasive Monitoring', 'description': 'Intervention: Device: Non invasive peripheral blood monitoring', 'interventionNames': ['Device: Non invasive peripheral blood monitoring']}], 'interventions': [{'name': 'Non invasive peripheral blood monitoring', 'type': 'DEVICE', 'description': 'non invasive monitoring', 'armGroupLabels': ['Non Invasive Monitoring']}]}, 'contactsLocationsModule': {'locations': [{'zip': '07962-1905', 'city': 'Morristown', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Atlantic Health - Morristown Memorial Hospital- Cardiovascular Medicine', 'geoPoint': {'lat': 40.79677, 'lon': -74.48154}}], 'overallOfficials': [{'name': 'Frank Smart, M.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chairman of the Cardiovascular Medicine Department at Morritwon Memorial Hospital and Atlantic Health'}, {'name': 'Yosef Segman, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Cnoga Medical Ltd.'}, {'name': 'Donna Hesari, BSN', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Atlantic Health System, Department of Cardiovascular Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cnoga Medical Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}