Ignite Creation Date:
2025-12-24 @ 11:24 PM
Ignite Modification Date:
2025-12-25 @ 9:10 PM
Study NCT ID:
NCT04253756
Status:
COMPLETED
Last Update Posted:
2022-06-06
First Post:
2020-01-25
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Randomized Trial Examining Plasma Exchange Using the Becton Dickinson (BD) Catheter In an Outpatient Apheresis Unit
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2022-03-18', 'type': 'ACTUAL'}}}}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'sonja.stutzman@utsouthwestern.edu', 'phone': '214-648-6719', 'title': 'Sonja Stutzman, Research Programs Manager', 'organization': 'University of Texas Southwestern Medical Center'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '12 months', 'description': 'When the return rate is out of the SOC parameters the SOC apheresis equipment (Optia or Cellex) will alarm. If the alarm sounds 3 times the RN will decrease inlet rate by 5 ml/sec until the minimum threshold is reached (if needed), which is 50 ml/sec for plasma exchange and 35 ml/sec for RBC exchange and 20 ml/sec for photopheresis. If the alarm continues to when the minimum threshold is reached the catheter will be replaced with the SOC 18-gauge catheter.', 'eventGroups': [{'id': 'EG000', 'title': '18-gauge Autogard Catheter', 'description': 'Standard of care', 'otherNumAtRisk': 13, 'deathsNumAtRisk': 13, 'otherNumAffected': 0, 'seriousNumAtRisk': 13, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': '20-gauge BD Nexiva Diffusics', 'description': 'Intervention\n\n20-gauge BD Nexiva Diffusics: The BD Nexiva Diffusics catheters are suitable for use with power injectors when a direct connection is made.', 'otherNumAtRisk': 13, 'deathsNumAtRisk': 13, 'otherNumAffected': 0, 'seriousNumAtRisk': 13, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Efficacy of Assigned Intervention as Measured by Plasma Hemoglobin Value', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '18G Catheter SOC (Control)', 'description': 'The standard of care is an 18-gauge autogard catheter (control group)'}, {'id': 'OG001', 'title': '20-gauge BD Nexiva Diffusics (Intervention)', 'description': '20-gauge BD Nexiva Diffusics: The BD Nexiva Diffusics catheters are suitable for use with power injectors when a direct connection is made.'}], 'classes': [{'categories': [{'measurements': [{'value': '16.8', 'spread': '9.64', 'groupId': 'OG000'}, {'value': '17.3', 'spread': '12.4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.87', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.5', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'The margin of non-inferiority (Delta) was 5g/dl'}], 'paramType': 'MEAN', 'timeFrame': '12 months', 'description': 'Efficacy of assigned intervention is measured by comparing the mean plasma hemoglobin values by group. Plasma hemoglobin test will be run on each patient to test for hemolysis (destruction of red blood cells which leads to the release of hemoglobin from the red blood cells into the blood plasma) which will be scored dichotomously as present or absent.', 'unitOfMeasure': 'g/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Efficacy of Assigned Intervention as Measured by the Amount of Time (Minutes) Required to Complete a TAP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '18G Catheter SOC (Control)', 'description': 'The standard of care is an 18-gauge autogard catheter (control group)'}, {'id': 'OG001', 'title': '20-gauge BD Nexiva Diffusics (Intervention)', 'description': '20-gauge BD Nexiva Diffusics: The BD Nexiva Diffusics catheters are suitable for use with power injectors when a direct connection is made.'}], 'classes': [{'categories': [{'measurements': [{'value': '90.1', 'spread': '14.3', 'groupId': 'OG000'}, {'value': '86.9', 'spread': '13.2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.32', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '3.2', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'The non-inferiority margin (Delta) was 10 minutes of run time, no other key parameters'}], 'paramType': 'MEAN', 'timeFrame': '12 months', 'description': 'Efficacy of assigned intervention is measured by comparing the time to complete the TAP in minutes and comparing the two treatment groups.', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Number of Adverse Events Experienced by Participants in Each Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '18G Catheter SOC (Control)', 'description': 'The standard of care is an 18-gauge autogard catheter (control group)'}, {'id': 'OG001', 'title': '20-gauge BD Nexiva Diffusics (Intervention)', 'description': '20-gauge BD Nexiva Diffusics: The BD Nexiva Diffusics catheters are suitable for use with power injectors when a direct connection is made.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 months', 'description': 'Number of adverse events experienced by participants in each group is being compared here.', 'unitOfMeasure': 'events', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants Experiencing a Return Pressure >400 mmHg', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '18G Catheter SOC (Control)', 'description': 'The standard of care is an 18-gauge autogard catheter (control group)'}, {'id': 'OG001', 'title': '20-gauge BD Nexiva Diffusics (Intervention)', 'description': '20-gauge BD Nexiva Diffusics: The BD Nexiva Diffusics catheters are suitable for use with power injectors when a direct connection is made.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 months', 'description': 'Number of participants experiencing a return pressure \\>400 mmHg when the return catheter occupies \\<45% of the inner-lumen diameter is being measured. The suggested standard is that a catheter occupies \\< 45% of the inner-lumen diameter (measured with ultrasound). Return pressures \\>400 mm Hg are considered problematic.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'All Study Participants', 'description': 'This includes participants where one half was assigned to 18G catheter SOC (control) and the other half be assigned to 20G BD Nexiva Diffusics catheter (intervention). Each participant may participate a maximum of 10 times.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}]}, {'type': 'Procedure 1: 18 Guage', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}]}, {'type': 'Procedure 1: 20 Gauge', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}]}, {'type': 'Procedure 2: 18 Gauge', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}]}, {'type': 'Procedure 2: 20 Gauge', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}]}, {'type': 'Procedure 3: 18 Gauge', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}]}, {'type': 'Procedure 3: 20 Gauge', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}]}, {'type': 'Procedure 4: 18 Gauge', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}]}, {'type': 'Procedure 4: 20 Gauge', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'Procedure 5: 18 Gauge', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Procedure 5: 20 Gauge', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'Procedure 6: 18 Gauge', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Procedure 6: 20 Gauge', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Procedure 7: 18 Gauge', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Procedure 7: 20 Gauge', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Procedure 8: 18 Gauge', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}, {'type': 'Procedure 8: 20 Gauge', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All Study Participants', 'description': 'This includes participants where one half was assigned to 18G catheter SOC (control) and the other half be assigned to 20G BD Nexiva Diffusics catheter (intervention). Each participant may participate a maximum of 10 times.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '45.2', 'spread': '14.2', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '16', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '23', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '15', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '26', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Due to the cross over study design, participants are represented as one Baseline group.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-04-22', 'size': 436131, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-05-10T19:11', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 26}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-03-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2021-05-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-05-11', 'studyFirstSubmitDate': '2020-01-25', 'resultsFirstSubmitDate': '2022-02-22', 'studyFirstSubmitQcDate': '2020-01-30', 'lastUpdatePostDateStruct': {'date': '2022-06-06', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-05-11', 'studyFirstPostDateStruct': {'date': '2020-02-05', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-06-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-04-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Efficacy of Assigned Intervention as Measured by Plasma Hemoglobin Value', 'timeFrame': '12 months', 'description': 'Efficacy of assigned intervention is measured by comparing the mean plasma hemoglobin values by group. Plasma hemoglobin test will be run on each patient to test for hemolysis (destruction of red blood cells which leads to the release of hemoglobin from the red blood cells into the blood plasma) which will be scored dichotomously as present or absent.'}, {'measure': 'Efficacy of Assigned Intervention as Measured by the Amount of Time (Minutes) Required to Complete a TAP', 'timeFrame': '12 months', 'description': 'Efficacy of assigned intervention is measured by comparing the time to complete the TAP in minutes and comparing the two treatment groups.'}, {'measure': 'Number of Adverse Events Experienced by Participants in Each Group', 'timeFrame': '12 months', 'description': 'Number of adverse events experienced by participants in each group is being compared here.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants Experiencing a Return Pressure >400 mmHg', 'timeFrame': '12 months', 'description': 'Number of participants experiencing a return pressure \\>400 mmHg when the return catheter occupies \\<45% of the inner-lumen diameter is being measured. The suggested standard is that a catheter occupies \\< 45% of the inner-lumen diameter (measured with ultrasound). Return pressures \\>400 mm Hg are considered problematic.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Plasma exchange', 'Photopheresis', 'Red blood Cell exchanges'], 'conditions': ['Plasma Exchange']}, 'referencesModule': {'references': [{'pmid': '29444733', 'type': 'BACKGROUND', 'citation': 'Spires SS, Rebeiro PF, Miller M, Koss K, Wright PW, Talbot TR. Medically Attended Catheter Complications Are Common in Patients With Outpatient Central Venous Catheters. Infect Control Hosp Epidemiol. 2018 Apr;39(4):439-444. doi: 10.1017/ice.2018.8. Epub 2018 Feb 15.'}, {'pmid': '23420596', 'type': 'BACKGROUND', 'citation': 'Golestaneh L, Mokrzycki MH. Vascular access in therapeutic apheresis: update 2013. J Clin Apher. 2013 Feb;28(1):64-72. doi: 10.1002/jca.21267.'}, {'pmid': '22535654', 'type': 'BACKGROUND', 'citation': 'Kalantari K. The choice of vascular access for therapeutic apheresis. J Clin Apher. 2012;27(3):153-9. doi: 10.1002/jca.21225. Epub 2012 Apr 26.'}, {'pmid': '29908838', 'type': 'BACKGROUND', 'citation': 'Keller SC, Williams D, Rock C, Deol S, Trexler P, Cosgrove SE. A new frontier: Central line-associated bloodstream infection surveillance in home infusion therapy. Am J Infect Control. 2018 Dec;46(12):1419-1421. doi: 10.1016/j.ajic.2018.05.016. Epub 2018 Jun 13. No abstract available.'}, {'pmid': '28217433', 'type': 'BACKGROUND', 'citation': 'Klimek L, Bergmann KC, Biedermann T, Bousquet J, Hellings P, Jung K, Merk H, Olze H, Schlenter W, Stock P, Ring J, Wagenmann M, Wehrmann W, Mosges R, Pfaar O. Visual analogue scales (VAS): Measuring instruments for the documentation of symptoms and therapy monitoring in cases of allergic rhinitis in everyday health care: Position Paper of the German Society of Allergology (AeDA) and the German Society of Allergy and Clinical Immunology (DGAKI), ENT Section, in collaboration with the working group on Clinical Immunology, Allergology and Environmental Medicine of the German Society of Otorhinolaryngology, Head and Neck Surgery (DGHNOKHC). Allergo J Int. 2017;26(1):16-24. doi: 10.1007/s40629-016-0006-7. Epub 2017 Jan 19.'}, {'pmid': '24656786', 'type': 'BACKGROUND', 'citation': 'Shang J, Ma C, Poghosyan L, Dowding D, Stone P. The prevalence of infections and patient risk factors in home health care: a systematic review. Am J Infect Control. 2014 May;42(5):479-84. doi: 10.1016/j.ajic.2013.12.018. Epub 2014 Mar 20.'}, {'pmid': '27630072', 'type': 'BACKGROUND', 'citation': 'Putensen D, Leverett D, Patel B, Rivera J. Is peripheral access for apheresis procedures underutilized in clinical practice?-A single centre experience. J Clin Apher. 2017 Dec;32(6):553-559. doi: 10.1002/jca.21508. Epub 2016 Sep 15.'}]}, 'descriptionModule': {'briefSummary': 'This is a randomized pilot study of therapeutic apheresis procedures (TAP) using the current standard of care catheter (SOC) vs the BD Nexiva Diffusics Catheter. It is a single blinded, randomized study. Data will be used to refine and power a full randomized control trial. For this study, a sample of 33 encounters in each group (total of 66 encounters). The specific aim is to test the hypothesis that the 20-gauge BD Nexiva Diffusics Catheter provides the same efficacy and lower pain level with no increase in adverse events for patients undergoing apheresis treatments.', 'detailedDescription': "TAP treats a wide range of disease processes and, in all cases, requires inlet and return venous access to perform the procedure. The goal of TAP is to return the patient to baseline and maintain independence and function. A larger needle (18 gauge) can cause more discomfort to the patient as well as additional scarring. A smaller needle may present less discomfort and scarring to the patient. The goal in the outpatient clinic is to minimize disruption to the patient's routine and help the patient maintain normal activities of daily living.\n\nTo accomplish these goals, the outpatient clinic is open Monday thru Friday offering 4 different appointment times. All patients that are referred to the clinic for TAP, first receive a vein evaluation to see if the patient is a candidate for peripheral IV therapy. At the clinic, approximately 68% of the patients TAP's are performed peripherally. This eliminates the risk of a central line infection and any alteration in activities of daily living, such as bathing(Kramer, 2016), (Shang, Ma, Poghosyan, Dowding, \\& Stone, 2014),(Keller et al., 2018; McDiarmid, 2015).\n\nThe hypothesis, is that the 20-gauge BD Nexiva Diffusics catheter provides the same efficacy as current practice with no increase in adverse events for patients undergoing therapeutic apheresis. The results from the study will be significant because if the 20 gauge needle is equally effective for TAP, it can increase the number of patients that would be candidates for peripheral therapy. Therefore, decreasing the need for central venous access, which place the patient at an increased risk of infection. The study is a comparison of 2 types of infusion catheters. The standard of care is an 18-gauge autogard catheter (control group) which will be compared to the 20-gauge BD Nexiva Diffusics (intervention).\n\nP - patients who require therapeutic apheresis procedures (TAP) I - use of 20 guage (20G) BD diffusics catheter during apheresis C - use of 18 G standard of care IV catheter during apheresis O - no difference in efficacy and no increase in safety events"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult (≥18 years old)\n* Speaks and reads English\n* A patient of the Apheresis clinic at University of Texas Southwestern University Hospital and Clinics\n* Scheduled to receive TAP (therapeutic plasma exchange, red blood cell exchange and extracorporeal Photopheresis) as standard of care\n\nExclusion Criteria:\n\n* Prisoners\n* Persons under the age of 18 years\n* Patient who are actively involved in chemotherapy'}, 'identificationModule': {'nctId': 'NCT04253756', 'acronym': 'REPLACE', 'briefTitle': 'A Randomized Trial Examining Plasma Exchange Using the Becton Dickinson (BD) Catheter In an Outpatient Apheresis Unit', 'organization': {'class': 'OTHER', 'fullName': 'University of Texas Southwestern Medical Center'}, 'officialTitle': 'A Randomized Trial Examining Plasma Exchange Using the Becton Dickinson (BD) Catheter In an Outpatient Apheresis Unit', 'orgStudyIdInfo': {'id': 'STU-2019-1363'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': '18-gauge autogard catheter', 'description': 'Standard of care'}, {'type': 'EXPERIMENTAL', 'label': '20-gauge BD Nexiva Diffusics', 'description': 'Intervention', 'interventionNames': ['Device: 20-gauge BD Nexiva Diffusics']}], 'interventions': [{'name': '20-gauge BD Nexiva Diffusics', 'type': 'DEVICE', 'description': 'The BD Nexiva Diffusics catheters are suitable for use with power injectors when a direct connection is made.', 'armGroupLabels': ['20-gauge BD Nexiva Diffusics']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75390', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Zale Lipshy Pavilion', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}], 'overallOfficials': [{'name': 'Tomas Armendariz, BSN', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UT Southwestern'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Texas Southwestern Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Becton, Dickinson and Company', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Tomas Armendariz', 'investigatorAffiliation': 'University of Texas Southwestern Medical Center'}}}}