Ignite Creation Date:
2025-12-24 @ 5:03 PM
Ignite Modification Date:
2026-02-24 @ 2:08 PM
Study NCT ID:
NCT02930850
Status:
COMPLETED
Last Update Posted:
2019-04-08
First Post:
2016-10-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Spot-Check Noninvasive Hemoglobin (SpHb) Clinical Validation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000740', 'term': 'Anemia'}, {'id': 'D054198', 'term': 'Precursor Cell Lymphoblastic Leukemia-Lymphoma'}], 'ancestors': [{'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007945', 'term': 'Leukemia, Lymphoid'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 447}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'dispFirstSubmitDate': '2019-04-01', 'completionDateStruct': {'date': '2016-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-01', 'studyFirstSubmitDate': '2016-10-10', 'dispFirstSubmitQcDate': '2019-04-01', 'studyFirstSubmitQcDate': '2016-10-10', 'dispFirstPostDateStruct': {'date': '2019-04-08', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2019-04-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-10-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Accuracy of hemoglobin measurement', 'timeFrame': 'Up to 2 hours per subject', 'description': 'Accuracy willl be determined by comparing the noninvasive hemoglobin measurement of the pulse oximeter to the hemoglobin value obtained from a blood sample and calculating the arithmetic root mean square(Arms) error value.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Anemia', 'Healthy', 'Pediatric ALL']}, 'descriptionModule': {'briefSummary': 'The purpose study is to report on the accuracy of noninvasive hemoglobin (SpHb) as compared to hemoglobin measurements obtained from a laboratory hematology analyzer.', 'detailedDescription': 'The primary objective of this clinical investigation is to report on the accuracy of the Rad-67 and DCI Mini sensor to measure SpHb as compared to hemoglobin measurements obtained from a manual HiCN analytical method and automated Beckman Coulter laboratory hematology analyzers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '1 Month', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age: Greater than one month\n* Weight: Greater than or equal to 3kg\n* The subject or the subject's legally authorized representative has given written informed consent/assent to participate in the study\n\nExclusion Criteria:\n\n* Subjects with skin abnormalities at the planned application sites that may interfere with sensor application, per directions-for-use (DFU) or trans-illumination of the site, such as burns, scar tissue, nail polish, acrylic nails, infections, abnormalities, etc.\n* Subjects deemed not suitable for the study at the discretion of the investigator\n* Subjects unlikely to be able to refrain from excessive motion during data collection. Excessive motion includes postural changes, making hand gestures, involuntary muscular movements, etc.\n* Decision-impaired adult and pediatric subjects who are unable to give consent and assent"}, 'identificationModule': {'nctId': 'NCT02930850', 'briefTitle': 'Spot-Check Noninvasive Hemoglobin (SpHb) Clinical Validation', 'organization': {'class': 'INDUSTRY', 'fullName': 'Masimo Corporation'}, 'officialTitle': 'Spot-Check Noninvasive Hemoglobin (SpHb) Clinical Validation', 'orgStudyIdInfo': {'id': 'TORR0002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Test subjects', 'description': 'All subjects are enrolled and receive Rad-67 Pulse oximeter sensor for measurement of hemoglobin.', 'interventionNames': ['Device: Rad-67 Pulse oximeter']}], 'interventions': [{'name': 'Rad-67 Pulse oximeter', 'type': 'DEVICE', 'description': 'Noninvasive pulse oximeter that measures hemoglobin', 'armGroupLabels': ['Test subjects']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Burbank', 'state': 'California', 'country': 'United States', 'facility': 'Site 4', 'geoPoint': {'lat': 34.18084, 'lon': -118.30897}}, {'city': 'Burbank', 'state': 'California', 'country': 'United States', 'facility': 'Site 5', 'geoPoint': {'lat': 34.18084, 'lon': -118.30897}}, {'city': 'Irvine', 'state': 'California', 'country': 'United States', 'facility': 'Site 2', 'geoPoint': {'lat': 33.66946, 'lon': -117.82311}}, {'city': 'Lake Forest', 'state': 'California', 'country': 'United States', 'facility': 'Site 7', 'geoPoint': {'lat': 33.64697, 'lon': -117.68922}}, {'city': 'National City', 'state': 'California', 'country': 'United States', 'facility': 'Site 3', 'geoPoint': {'lat': 32.67811, 'lon': -117.0992}}, {'city': 'Torrance', 'state': 'California', 'country': 'United States', 'facility': 'Site 6', 'geoPoint': {'lat': 33.83585, 'lon': -118.34063}}, {'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Site 1', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Masimo Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}