Ignite Creation Date:
2025-12-24 @ 3:56 PM
Ignite Modification Date:
2026-01-31 @ 8:19 AM
Study NCT ID:
NCT03650192
Status:
COMPLETED
Last Update Posted:
2021-01-29
First Post:
2018-08-27
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
INVSENSOR00027 Clinical Performance Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2020-06-05', 'type': 'ACTUAL'}}}}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'studies@masimo.com', 'phone': '949-297-7000', 'title': 'Ahmed Alghazi', 'organization': 'Masimo'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse event data was collected over the course of the study (35 days).', 'eventGroups': [{'id': 'EG000', 'title': 'INVSENSOR00027 Test Group', 'description': "The subjects will be enrolled into the test group and will receive the INVSENSOR00027 investigational sensor.\n\nINVSENSOR00027: Investigational, noninvasive sensor that will be placed on the subject's chest and/or back. INVSENSOR00027 measures signals regarding subject's movement and posture, heart rate, and respiratory rate.", 'otherNumAtRisk': 40, 'deathsNumAtRisk': 40, 'otherNumAffected': 0, 'seriousNumAtRisk': 40, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': "Sensitivity of INVSENSOR00027's Posture Change Detection", 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'INVSENSOR00027 Test Group', 'description': "The subjects will be enrolled into the test group and will receive the INVSENSOR00027 investigational sensor.\n\nINVSENSOR00027: Investigational, noninvasive sensor that will be placed on the subject's chest and/or back. INVSENSOR00027 measures signals regarding subject's movement and posture, heart rate, and respiratory rate."}], 'classes': [{'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1-5 hours', 'description': "For each subject's position detection, INVSENSOR00027 output will be compared against observer's notes at each turn of the subject. Correctly detected position changes will be marked as True Positive. Missed detections (if any) will be counted. The sensitivity of INVSENSOR00027's posture change detection will be computed as Sensitivity = True Positive/(True Positive+Missed Detection)", 'unitOfMeasure': 'percent sensitivity for posture change', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': "Sensitivity of INVSENSOR00027's Activity Change Detection", 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'INVSENSOR00027 Test Group', 'description': "The subjects will be enrolled into the test group and will receive the INVSENSOR00027 investigational sensor.\n\nINVSENSOR00027: Investigational, noninvasive sensor that will be placed on the subject's chest and/or back. INVSENSOR00027 measures signals regarding subject's movement and posture, heart rate, and respiratory rate."}], 'classes': [{'categories': [{'measurements': [{'value': '96.7', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1-5 hours', 'description': "For each subject's activity (e.g., walking and upright) detection, INVSENSOR00027 output will be compared against observer's notes. Correctly detected activity changes will be marked as True Positive. Missed detections (if any) will be counted. The sensitivity of INVSENSOR00027's activity change detection will be computed as Sensitivity = True Positive/(True Positive+Missed Detection).", 'unitOfMeasure': 'percent sensitivity for posture change', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': "Sensitivity of INVSENSOR00027's Fall Event Detection", 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'INVSENSOR00027 Test Group', 'description': "The subjects will be enrolled into the test group and will receive the INVSENSOR00027 investigational sensor.\n\nINVSENSOR00027: Investigational, noninvasive sensor that will be placed on the subject's chest and/or back. INVSENSOR00027 measures signals regarding subject's movement and posture, heart rate, and respiratory rate."}], 'classes': [{'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1-5 hours', 'unitOfMeasure': 'percent sensitivity for fall detection', 'reportingStatus': 'POSTED', 'populationDescription': 'Fall detection was an optional event per protocol.'}, {'type': 'SECONDARY', 'title': 'Respiratory Rate Detection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'INVSENSOR00027 Test Group', 'description': "The subjects will be enrolled into the test group and will receive the INVSENSOR00027 investigational sensor.\n\nINVSENSOR00027: Investigational, noninvasive sensor that will be placed on the subject's chest and/or back. INVSENSOR00027 measures signals regarding subject's movement and posture, heart rate, and respiratory rate."}], 'classes': [{'categories': [{'measurements': [{'value': '1.7', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1-5 hours', 'description': 'Accuracy will be determined by comparing the respiratory rate measurement of the INVSENSOR00027 to the respiratory rate reference (RRef) and calculating the arithmetic root mean square (Arms) value. In order to obtain the Arms value, the RR measurement from the reference is subtracted from the INVSENSOR00027 RR measurement for a number of samples. The average of this difference is computed as the bias. The standard deviation of the differences is computed as the precision. The square root of the sum of the squares of bias and precision is computed as the Arms value.', 'unitOfMeasure': 'A(RMS) of breaths per minute', 'reportingStatus': 'POSTED', 'populationDescription': '2 subjects were excluded due to data collection issues.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'INVSENSOR00027 Test Group', 'description': "The subjects will be enrolled into the test group and will receive the INVSENSOR00027 investigational sensor.\n\nINVSENSOR00027: Investigational, noninvasive sensor that will be placed on the subject's chest and/or back. INVSENSOR00027 measures signals regarding subject's movement and posture, heart rate, and respiratory rate."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '40'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '40'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'INVSENSOR00027 Test Group', 'description': "The subjects will be enrolled into the test group and will receive the INVSENSOR00027 investigational sensor.\n\nINVSENSOR00027: Investigational, noninvasive sensor that will be placed on the subject's chest and/or back. INVSENSOR00027 measures signals regarding subject's movement and posture, heart rate, and respiratory rate."}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '38', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '22', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '18', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'African American', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}]}]}, {'title': 'Asian or Pacific Islander', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}, {'title': 'Caucasian', 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}]}]}, {'title': 'Hispanic', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}, {'title': 'Native American', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '40', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-08-07', 'size': 220561, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-05-15T15:21', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-08-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'dispFirstSubmitDate': '2019-09-19', 'completionDateStruct': {'date': '2018-09-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-08', 'studyFirstSubmitDate': '2018-08-27', 'dispFirstSubmitQcDate': '2021-01-08', 'resultsFirstSubmitDate': '2020-05-15', 'studyFirstSubmitQcDate': '2018-08-27', 'dispFirstPostDateStruct': {'date': '2021-01-29', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2021-01-29', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-01-08', 'studyFirstPostDateStruct': {'date': '2018-08-28', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-01-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-09-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Sensitivity of INVSENSOR00027's Posture Change Detection", 'timeFrame': '1-5 hours', 'description': "For each subject's position detection, INVSENSOR00027 output will be compared against observer's notes at each turn of the subject. Correctly detected position changes will be marked as True Positive. Missed detections (if any) will be counted. The sensitivity of INVSENSOR00027's posture change detection will be computed as Sensitivity = True Positive/(True Positive+Missed Detection)"}, {'measure': "Sensitivity of INVSENSOR00027's Activity Change Detection", 'timeFrame': '1-5 hours', 'description': "For each subject's activity (e.g., walking and upright) detection, INVSENSOR00027 output will be compared against observer's notes. Correctly detected activity changes will be marked as True Positive. Missed detections (if any) will be counted. The sensitivity of INVSENSOR00027's activity change detection will be computed as Sensitivity = True Positive/(True Positive+Missed Detection)."}, {'measure': "Sensitivity of INVSENSOR00027's Fall Event Detection", 'timeFrame': '1-5 hours'}], 'secondaryOutcomes': [{'measure': 'Respiratory Rate Detection', 'timeFrame': '1-5 hours', 'description': 'Accuracy will be determined by comparing the respiratory rate measurement of the INVSENSOR00027 to the respiratory rate reference (RRef) and calculating the arithmetic root mean square (Arms) value. In order to obtain the Arms value, the RR measurement from the reference is subtracted from the INVSENSOR00027 RR measurement for a number of samples. The average of this difference is computed as the bias. The standard deviation of the differences is computed as the precision. The square root of the sum of the squares of bias and precision is computed as the Arms value.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': "This study assesses the investigational sensor's (INVSENSOR00027) performance for detection of subjects' position and posture in bed, along with heart rate and respiratory rate."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* 18 to 80 years old\n* Physical status of ASA I or II\n* Subjects must be able to read and communicate in English\n* Has signed all necessary related documents, e.g. written informed consent, volunteer payment form, confidentiality agreement\n* Has completed Health Assessment Questionnaire and passed health assessment screening\n\nExclusion Criteria:\n\n* Subject has any medical condition which in the judgment of the investigator, renders them inappropriate for participation in this study\n* Inability to tolerate sitting still or minimal movement for at least 30 minutes\n* Nursing female volunteers\n* Excluded at the Principal Investigator's discretion\n* Refusal to take the pregnancy test (for female subjects)\n* Positive pregnancy test for female subjects of child bearing potential. This is done for the safety of this population.\n* Refusal to shave hair (neck, chest) off areas where sensors will be applied (male subjects)"}, 'identificationModule': {'nctId': 'NCT03650192', 'briefTitle': 'INVSENSOR00027 Clinical Performance Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Masimo Corporation'}, 'officialTitle': 'INVSENSOR00027 Clinical Performance Study', 'orgStudyIdInfo': {'id': 'TP-19415'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'INVSENSOR00027 Test group', 'description': 'The subjects will be enrolled into the test group and will receive the INVSENSOR00027 investigational sensor.', 'interventionNames': ['Device: INVSENSOR00027']}], 'interventions': [{'name': 'INVSENSOR00027', 'type': 'DEVICE', 'description': "Investigational, noninvasive sensor that will be placed on the subject's chest and/or back. INVSENSOR00027 measures signals regarding subject's movement and posture, heart rate, and respiratory rate.", 'armGroupLabels': ['INVSENSOR00027 Test group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92618', 'city': 'Irvine', 'state': 'California', 'country': 'United States', 'facility': 'Masimo Clinical Lab', 'geoPoint': {'lat': 33.66946, 'lon': -117.82311}}], 'overallOfficials': [{'name': 'Ahmed Alghazi', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Masimo Corporation'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Masimo Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}