Ignite Creation Date:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2025-12-30 @ 4:50 AM
Study NCT ID:
NCT01646060
Status:
COMPLETED
Last Update Posted:
2012-07-20
First Post:
2011-11-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Evaluation of the Zynex Blood Volume Monitor (CM-1500) in Healthy Male Adult Subjects During a Blood Draw
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006470', 'term': 'Hemorrhage'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-07', 'completionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-07-17', 'studyFirstSubmitDate': '2011-11-28', 'studyFirstSubmitQcDate': '2012-07-17', 'lastUpdatePostDateStruct': {'date': '2012-07-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-07-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Detect change in blood volume during blood draw', 'timeFrame': '15-30 minutes'}], 'secondaryOutcomes': [{'measure': 'Detect insidious bleeding', 'timeFrame': '15-30 minutes'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['blood', 'loss', 'healthy', 'volume', 'To evaluate the ability of the Zynex BVM to non-invasively detect blood loss in healthy subjects during a blood draw.'], 'conditions': ['Blood Loss', 'Healthy']}, 'descriptionModule': {'briefSummary': "Zynex's blood volume monitor (BVM) is a non-invasive monitoring device to monitor blood volume and blood loss of a patient during surgery, post operatively and/or in recovery. This monitoring device will identify baseline blood volume and relative changes in blood volume using a specific algorithm to compare and review data already monitored during surgery, displaying blood volume and blood loss in real-time."}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Written informed consent\n* Male, 18-65 years of age\n* Subject is suitable for a blood draw of a pint of blood\n* Weighs at least 110 pounds\n\nExclusion Criteria:\n\n* Subject has a heart condition that may interfere with the Zynex CM-1500\n* Subject has unstable or untreated heart disease\n* Subject has been diagnosed with chronic fatigue syndrome\n* Subject is taking coumadin (warfarin), heparin, or other prescription blood thinners for at least 7 days prior to blood draw\n* Subject donated blood within 8 weeks prior to blood draw\n* Subject has high or low blood pressure on the day of blood draw\n* Subject hemoglobin \\< 12.5 g/dL'}, 'identificationModule': {'nctId': 'NCT01646060', 'briefTitle': 'Clinical Evaluation of the Zynex Blood Volume Monitor (CM-1500) in Healthy Male Adult Subjects During a Blood Draw', 'organization': {'class': 'INDUSTRY', 'fullName': 'Zynex Monitoring Solutions'}, 'officialTitle': 'Clinical Evaluation of the Zynex Blood Volume Monitor (CM-1500) in Healthy Male Adult Subjects During a Blood Draw', 'orgStudyIdInfo': {'id': 'ZM-11-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Blood Draw', 'interventionNames': ['Device: CM-1500']}], 'interventions': [{'name': 'CM-1500', 'type': 'DEVICE', 'description': 'Blood Volume Monitor', 'armGroupLabels': ['Blood Draw']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80012', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'Rocky Mountain Urgent Care', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}], 'overallOfficials': [{'name': 'Nathaniel Moore, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rocky Mountain Urgent Care'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zynex Monitoring Solutions', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}