Ignite Creation Date:
2025-12-24 @ 10:33 PM
Ignite Modification Date:
2026-04-14 @ 12:56 PM
Study NCT ID:
NCT03125135
Status:
COMPLETED
Last Update Posted:
2021-02-02
First Post:
2017-04-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Accuracy of Noninvasive Pulse Oximeter Sensor (MightySat RX)
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': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-11-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2014-12-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-29', 'studyFirstSubmitDate': '2017-04-14', 'studyFirstSubmitQcDate': '2017-04-20', 'lastUpdatePostDateStruct': {'date': '2021-02-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-04-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-12-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Accuracy of Sensor', 'timeFrame': '1-5 hours', 'description': 'Accuracy will be determined by comparing the noninvasive blood oxygen saturation measurement of the pulse oximeter to that obtained from a blood sample and calculating the arithmetic root mean square error (Arms) value.'}, {'measure': 'Accuracy of Sensor during motion', 'timeFrame': '1-5 hours', 'description': 'Accuracy will be determined by comparing the noninvasive blood oxygen saturation measurement of the pulse oximeter to that obtained from a blood sample during motion conditions and calculating the arithmetic root mean square error (Arms) value.'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'In this study, the level of oxygen within the blood will be reduced in a controlled manner by reducing the concentration of oxygen the study volunteer breathes. The accuracy of a noninvasive pulse oximeter sensor will be assessed by comparison to the oxygen saturation measurements from a laboratory blood gas analyzer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Competent non-smoking adults\n\nInclusion Criteria:\n\n* Subjects must understand and consent to be in the study.\n* American Society of Anesthesiology Class 1 (Healthy subjects without any systemic disease at all).\n\nExclusion Criteria:\n\n* Subjects who have any systemic disease at all.\n* Subjects who do not understand the study and the risks.\n* Smokers.\n* Subjects who are pregnant.\n* Subjects having either signs or history of peripheral ischemia.\n* Others deemed ineligible by the clinical staff.'}, 'identificationModule': {'nctId': 'NCT03125135', 'briefTitle': 'Accuracy of Noninvasive Pulse Oximeter Sensor (MightySat RX)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Masimo Corporation'}, 'orgStudyIdInfo': {'id': 'TR27761-TP16850A'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Test Subject', 'description': 'All subjects are enrolled into the test group and all subjects receive the MightySat RX Pulse Oximeter Sensor.', 'interventionNames': ['Device: MightySat RX Pulse Oximeter Sensor']}], 'interventions': [{'name': 'MightySat RX Pulse Oximeter Sensor', 'type': 'DEVICE', 'description': 'Noninvasive pulse oximeter finger sensor.', 'armGroupLabels': ['Test Subject']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92618', 'city': 'Irvine', 'state': 'California', 'country': 'United States', 'facility': 'Masimo Corporation', 'geoPoint': {'lat': 33.66946, 'lon': -117.82311}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Masimo Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}