Ignite Creation Date:
2025-12-24 @ 2:10 PM
Ignite Modification Date:
2026-02-20 @ 4:44 PM
Study NCT ID:
NCT01846195
Status:
COMPLETED
Last Update Posted:
2022-11-09
First Post:
2013-03-13
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Evaluation of the Zynex Blood Volume Monitor in Healthy Adult Patients During a Blood Draw
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'dgregg@zynex.com', 'phone': '1-800-495-6670', 'title': 'Donald Gregg', 'organization': 'Zynex Monitoring Solutions'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Adverse event data was collected through the completion of the study. Adverse events per subject may have occurred during the blood draw or within 24 hours following with any potential reaction to electrode adhesive.', 'eventGroups': [{'id': 'EG000', 'title': 'no Blood Draw', 'description': 'CM 1500 with no blood draw\n\nCM 1500', 'otherNumAtRisk': 5, 'deathsNumAtRisk': 5, 'otherNumAffected': 0, 'seriousNumAtRisk': 5, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Blood Draw', 'description': 'CM 1500 with blood draw\n\nCM 1500', 'otherNumAtRisk': 45, 'deathsNumAtRisk': 45, 'otherNumAffected': 5, 'seriousNumAtRisk': 45, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Vasovagal Reaction to Blood Draw', 'notes': 'Several subjects had a vasovagal reaction to the blood draw. Specifically, subject reported being lightheaded or dizzy.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Detect by Non-invasive Monitoring a Change in Blood Volume During a Whole Blood Draw', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'no Blood Draw', 'description': 'CM 1500 with no blood draw\n\nCM 1500'}, {'id': 'OG001', 'title': 'Blood Draw', 'description': 'CM 1500 with blood draw\n\nCM 1500'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At study completion (completion of blood draw)', 'description': 'Detection by non-invasive monitoring a change in blood volume (yes or no) during a whole blood draw', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of subjects for which blood loss was detected.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'no Blood Draw', 'description': 'CM 1500 with no blood draw\n\nCM 1500'}, {'id': 'FG001', 'title': 'Blood Draw', 'description': 'CM 1500 with blood draw\n\nCM 1500'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '45'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '45'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'no Blood Draw', 'description': 'CM 1500 with no blood draw\n\nCM 1500'}, {'id': 'BG001', 'title': 'Blood Draw', 'description': 'CM 1500 with blood draw\n\nCM 1500'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '25.5', 'groupId': 'BG000', 'lowerLimit': '18', 'upperLimit': '33'}, {'value': '25.9', 'groupId': 'BG001', 'lowerLimit': '18', 'upperLimit': '34'}, {'value': '25.7', 'groupId': 'BG002', 'lowerLimit': '18', 'upperLimit': '34'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Height', 'classes': [{'categories': [{'measurements': [{'value': '69.2', 'groupId': 'BG000', 'lowerLimit': '65', 'upperLimit': '73'}, {'value': '67.9', 'groupId': 'BG001', 'lowerLimit': '62', 'upperLimit': '75'}, {'value': '68.6', 'groupId': 'BG002', 'lowerLimit': '62', 'upperLimit': '75'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'inches', 'dispersionType': 'FULL_RANGE'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '162.3', 'groupId': 'BG000', 'lowerLimit': '136', 'upperLimit': '196'}, {'value': '158.4', 'groupId': 'BG001', 'lowerLimit': '134', 'upperLimit': '196'}, {'value': '160.4', 'groupId': 'BG002', 'lowerLimit': '134', 'upperLimit': '196'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'pounds', 'dispersionType': 'FULL_RANGE'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-06-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2013-03-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-10-13', 'studyFirstSubmitDate': '2013-03-13', 'resultsFirstSubmitDate': '2022-08-03', 'studyFirstSubmitQcDate': '2013-04-30', 'lastUpdatePostDateStruct': {'date': '2022-11-09', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-10-13', 'studyFirstPostDateStruct': {'date': '2013-05-03', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2022-11-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2013-03-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Detect by Non-invasive Monitoring a Change in Blood Volume During a Whole Blood Draw', 'timeFrame': 'At study completion (completion of blood draw)', 'description': 'Detection by non-invasive monitoring a change in blood volume (yes or no) during a whole blood draw'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['blood loss'], 'conditions': ['Blood Loss']}, 'descriptionModule': {'briefSummary': 'Non-invasive monitoring to measure changes in blood volume.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy volunteers\n* Between 18-35 years of age\n* Weight between 130-200 pounds\n\nExclusion Criteria:\n\n* Known cardiac disease\n* Recent caffeine intake\n* Tobacco use in the (4) hours prior to screening\n* Infection\n* Pregnancy\n* Hemoglobin \\<13.5 g/dl'}, 'identificationModule': {'nctId': 'NCT01846195', 'briefTitle': 'Evaluation of the Zynex Blood Volume Monitor in Healthy Adult Patients During a Blood Draw', 'organization': {'class': 'INDUSTRY', 'fullName': 'Zynex Monitoring Solutions'}, 'officialTitle': 'Clinical Evaluation of the Zynex Blood Volume Monitor (CM-1500) in Healthy Adult Patients During a Blood Draw', 'orgStudyIdInfo': {'id': 'Zynex500'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'SHAM_COMPARATOR', 'label': 'no blood draw', 'description': 'CM 1500 with no blood draw', 'interventionNames': ['Device: CM 1500']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'blood draw', 'description': 'CM 1500 with blood draw', 'interventionNames': ['Device: CM 1500']}], 'interventions': [{'name': 'CM 1500', 'type': 'DEVICE', 'armGroupLabels': ['blood draw', 'no blood draw']}]}, 'contactsLocationsModule': {'locations': [{'zip': '84107', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'Premier Research Group', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}], 'overallOfficials': [{'name': 'John Ziegler, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Premier Research'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zynex Monitoring Solutions', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'DTarget', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}