Ignite Creation Date:
2025-12-24 @ 1:37 PM
Ignite Modification Date:
2026-01-18 @ 6:37 PM
Study NCT ID:
NCT02262195
Status:
COMPLETED
Last Update Posted:
2015-04-21
First Post:
2014-10-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dysfunctional Hemoglobin
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 62}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-10', 'completionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-04-20', 'studyFirstSubmitDate': '2014-10-07', 'studyFirstSubmitQcDate': '2014-10-07', 'lastUpdatePostDateStruct': {'date': '2015-04-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-10-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluate carboxyhemoglobin over the range of 0-15 percent as assessed by co-oximetry', 'timeFrame': '4 hours'}, {'measure': 'Evaluate methemoglobin over the range of 0-15 percent as assessed by co-oximetry', 'timeFrame': '4 hours'}], 'secondaryOutcomes': [{'measure': 'Determine oxygen saturation accuracy in conditions of elevated carboxyhemoglobin', 'timeFrame': '4 hours'}, {'measure': 'Determine oxygen saturation accuracy in conditions of elevated methemoglobin', 'timeFrame': '4 hours'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Elevated Levels of Carboxyhemoglobin and Methemoglobin']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to determine if a new pulse oximeter accurately detects carboxyhemoglobin and methemoglobin when intentionally increased in the blood.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Healthy Adult volunteers', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects does not have significant medical problems\n* Subject is willing to provide written informed consent\n* Subject is between 18 and 45 years of age\n\nExclusion Criteria:\n\n* Has a BMI greater than 31\n* Has had any relevant injury at the sensor location site\n* Has deformities or abnormalities that may prevent proper application of the device under test\n* Has a known respiratory condition\n* Is currently a smoker\n* Has a known heart or cardiovascular condition\n* Is currently pregnant\n* Is female and actively trying to get pregnant\n* Has a clotting disorder\n* Is known to have a hemoglobinopathy such as (anemia, bilirubinemia, sickle-cell anemia, inherited or congenital methemoglobinemia)\n* The subject has a COHb greater than 3% or MetHb greater than 2%\n* Has taken blood thinners or medication with aspirin within the last 24 hours\n* Has unacceptable collateral circulation from the ulnar artery\n* Has donated more than 300 mL of blood within one month prior to start of study\n* Is unwilling or unable to provide written informed consent to participate in the study\n* Is unwilling or unable to comply with the study procedures\n* Has another health condition which in the opinion of the principal investigator makes him/her unsuitable for testing'}, 'identificationModule': {'nctId': 'NCT02262195', 'briefTitle': 'Dysfunctional Hemoglobin', 'organization': {'class': 'INDUSTRY', 'fullName': 'Nonin Medical, Inc'}, 'officialTitle': 'Dysfunctional Hemoglobin Pulse Co-ox', 'orgStudyIdInfo': {'id': 'QATP2338'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Carboxyhemoglobin', 'description': 'Induced carboxyhemoglobin levels up tp 15 percent.', 'interventionNames': ['Other: Elevated levels of carboxyhemoglobin']}, {'label': 'Methemoglobin', 'description': 'Induced methemoglobin levels up to 15 percent.', 'interventionNames': ['Other: Elevated levels of carboxyhemoglobin']}], 'interventions': [{'name': 'Elevated levels of carboxyhemoglobin', 'type': 'OTHER', 'otherNames': ['Elevated levels of methemoglobin'], 'description': 'Comparison of pulse co-oximeters', 'armGroupLabels': ['Carboxyhemoglobin', 'Methemoglobin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94118', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'University of California San Francisco', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}], 'overallOfficials': [{'name': 'Phillip E Bickler, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of San Francisco'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nonin Medical, Inc', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'University of California, San Francisco', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}