Ignite Creation Date:
2025-12-24 @ 9:24 PM
Ignite Modification Date:
2026-01-01 @ 9:51 PM
Study NCT ID:
NCT05228132
Status:
TERMINATED
Last Update Posted:
2024-04-11
First Post:
2022-01-27
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
The Pristine Post-Market Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2024-01-17', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D007676', 'term': 'Kidney Failure, Chronic'}], 'ancestors': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'joshua.black@bd.com', 'phone': '520-599-6124', 'title': 'Joshua Black, Clinical Project Manager', 'organization': 'Becton Dickinson'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Early termination was due to considerable changes in the clinical landscape post Covid-19, leading to difficulties executing the study. Results were not source verified nor study data analyzed prior to termination. Given the sample size no analysis was performed on the limited data available.'}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were collected from Index Procedure to the 1-month Endpoint or until study termination which on average was 42 days, a minimum of 17 days, and a maximum of 77 days.', 'eventGroups': [{'id': 'EG000', 'title': 'Pristine™ Long-Term Hemodialysis Catheter', 'description': 'The Pristine™ Long-Term Hemodialysis Catheter is a chronic hemodialysis catheter consisting of a dual lumen radiopaque shaft with a pre-formed split tip, which enables long-term vascular access for hemodialysis. The device is intended to be used in patients suffering from chronic kidney disease. The Pristine™ Catheter will be placed according to the Instructions for Use (IFU).\n\nPristine™ Long-Term Hemodialysis Catheter: Placement of the Pristine™ Long-Term Hemodialysis Catheter Placement.', 'otherNumAtRisk': 7, 'deathsNumAtRisk': 7, 'otherNumAffected': 2, 'seriousNumAtRisk': 7, 'deathsNumAffected': 0, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'Procedural pain', 'notes': 'Procedural Pain - Acute Post-Op Pain - Day 0 - Not device related, Likely procedure related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Dizziness', 'notes': 'Dizziness - Day 40 - Not procedure or device related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Not Device Related-Septic Shock', 'notes': 'Sepsis - bacteraemia, viraemia and fungaemia - Day 17 - Not Related to Device or Procedure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Device Related-Thrombosis in device', 'notes': 'Thrombosis in device - Clotted Catheter - Day 55 - Likely device related, Unlikely procedure related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Product Issues', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Device Related-Thrombosis in device', 'notes': 'Thrombosis in device - Clotted Catheter - Day 20 - Likely device related, Not procedure related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Product Issues', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Overall Complication Rate of the Pristine™ Catheter', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Pristine™ Long-Term Hemodialysis Catheter', 'description': 'The Pristine™ Long-Term Hemodialysis Catheter is a chronic hemodialysis catheter consisting of a dual lumen radiopaque shaft with a pre-formed split tip, which enables long-term vascular access for hemodialysis. The device is intended to be used in patients suffering from chronic kidney disease. The Pristine™ Catheter will be placed according to the Instructions for Use (IFU).\n\nPristine™ Long-Term Hemodialysis Catheter: Placement of the Pristine™ Long-Term Hemodialysis Catheter Placement.'}], 'timeFrame': 'At 3 months post index procedure.', 'description': 'The combined Primary Endpoint is the overall rate of infectious complications and non-infectious complications requiring revision to maintain patency and improve access performance, evaluated against a performance goal (PG) derived from the Dialysis Outcomes and Practice Patterns Study (DOPPS) data.', 'reportingStatus': 'POSTED', 'populationDescription': 'No participants were followed out to the 3-Month follow-up thus the primary endpoint analysis was not performed. With no source verification or analysis performed, there may be inaccurate reporting and potential misrepresentation of the result.'}, {'type': 'SECONDARY', 'title': 'Rate of Freedom From Catheter-related Bloodstream Infection (CRBSI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Pristine™ Long-Term Hemodialysis Catheter', 'description': 'The Pristine™ Long-Term Hemodialysis Catheter is a chronic hemodialysis catheter consisting of a dual lumen radiopaque shaft with a pre-formed split tip, which enables long-term vascular access for hemodialysis. The device is intended to be used in patients suffering from chronic kidney disease. The Pristine™ Catheter will be placed according to the Instructions for Use (IFU).\n\nPristine™ Long-Term Hemodialysis Catheter: Placement of the Pristine™ Long-Term Hemodialysis Catheter Placement.'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1-month Post-Index Procedure.', 'description': '2019 KDOQI Guidelines for CRBSI defined as, clinical manifestations and at least 1 positive blood culture result from a peripheral source (dialysis circuit or vein) and no other apparent source, with either positive semiquantitative (\\>15 CFU/catheter segment, hub or tip) or quantitative (\\>102 CFU/catheter segment, eg, hub or tip) culture, whereby the same organism (species and antibiogram) is isolated from the catheter segment (eg, hub or tip) and a peripheral source (dialysis circuit or vein) blood sample.', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'No data was collected out to the timepoints following 1-month due to early study termination.'}, {'type': 'SECONDARY', 'title': 'Rate of Freedom From Device and/or Procedure-related Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Pristine™ Long-Term Hemodialysis Catheter', 'description': 'The Pristine™ Long-Term Hemodialysis Catheter is a chronic hemodialysis catheter consisting of a dual lumen radiopaque shaft with a pre-formed split tip, which enables long-term vascular access for hemodialysis. The device is intended to be used in patients suffering from chronic kidney disease. The Pristine™ Catheter will be placed according to the Instructions for Use (IFU).\n\nPristine™ Long-Term Hemodialysis Catheter: Placement of the Pristine™ Long-Term Hemodialysis Catheter Placement.'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1-month Post-Index Procedure.', 'description': 'Number of participants free from Device and/or Procedure-related adverse events.', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'No data was collected out to the timepoints following 1-month due to early study termination.'}, {'type': 'SECONDARY', 'title': 'Rate of Technical Success', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Pristine™ Long-Term Hemodialysis Catheter', 'description': 'The Pristine™ Long-Term Hemodialysis Catheter is a chronic hemodialysis catheter consisting of a dual lumen radiopaque shaft with a pre-formed split tip, which enables long-term vascular access for hemodialysis. The device is intended to be used in patients suffering from chronic kidney disease. The Pristine™ Catheter will be placed according to the Instructions for Use (IFU).\n\nPristine™ Long-Term Hemodialysis Catheter: Placement of the Pristine™ Long-Term Hemodialysis Catheter Placement.'}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At time of Index Procedure.', 'description': 'Number of Participants with successful placement of the Pristine™ Long-Term Hemodialysis Catheter', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'No data was collected out to the timepoints following 1-month due to early study termination.'}, {'type': 'SECONDARY', 'title': 'Overall Participant Survival Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Pristine™ Long-Term Hemodialysis Catheter', 'description': 'The Pristine™ Long-Term Hemodialysis Catheter is a chronic hemodialysis catheter consisting of a dual lumen radiopaque shaft with a pre-formed split tip, which enables long-term vascular access for hemodialysis. The device is intended to be used in patients suffering from chronic kidney disease. The Pristine™ Catheter will be placed according to the Instructions for Use (IFU).\n\nPristine™ Long-Term Hemodialysis Catheter: Placement of the Pristine™ Long-Term Hemodialysis Catheter Placement.'}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1-month Post-Index Procedure.', 'description': 'Number of participants that have not died from any catheter related complication.', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'No data was collected out to the timepoints following 1-month due to early study termination.'}, {'type': 'SECONDARY', 'title': 'Overall Catheter Survival Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Pristine™ Long-Term Hemodialysis Catheter', 'description': 'The Pristine™ Long-Term Hemodialysis Catheter is a chronic hemodialysis catheter consisting of a dual lumen radiopaque shaft with a pre-formed split tip, which enables long-term vascular access for hemodialysis. The device is intended to be used in patients suffering from chronic kidney disease. The Pristine™ Catheter will be placed according to the Instructions for Use (IFU).\n\nPristine™ Long-Term Hemodialysis Catheter: Placement of the Pristine™ Long-Term Hemodialysis Catheter Placement.'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1-month Post-Index Procedure', 'description': 'Number of participants with whom the Pristine™ Catheters have not been removed for any cause.', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'No data was collected out to the timepoints following 1-month due to early study termination.'}, {'type': 'SECONDARY', 'title': 'Overall Patency Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Pristine™ Long-Term Hemodialysis Catheter', 'description': 'The Pristine™ Long-Term Hemodialysis Catheter is a chronic hemodialysis catheter consisting of a dual lumen radiopaque shaft with a pre-formed split tip, which enables long-term vascular access for hemodialysis. The device is intended to be used in patients suffering from chronic kidney disease. The Pristine™ Catheter will be placed according to the Instructions for Use (IFU).\n\nPristine™ Long-Term Hemodialysis Catheter: Placement of the Pristine™ Long-Term Hemodialysis Catheter Placement.'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1-month Post-Index Procedure', 'description': 'Number of participants with their Pristine™ catheter having the ability to achieve a mean dialysis blood flow of ≥300mL/min without need for additional interventions.', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'No data was collected out to the timepoints following 1-month due to early study termination.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Kit Component Safety and Performance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Pristine™ Long-Term Hemodialysis Catheter', 'description': 'The Pristine™ Long-Term Hemodialysis Catheter is a chronic hemodialysis catheter consisting of a dual lumen radiopaque shaft with a pre-formed split tip, which enables long-term vascular access for hemodialysis. The device is intended to be used in patients suffering from chronic kidney disease. The Pristine™ Catheter will be placed according to the Instructions for Use (IFU).\n\nPristine™ Long-Term Hemodialysis Catheter: Placement of the Pristine™ Long-Term Hemodialysis Catheter Placement.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From Index Procedure to Discharge, of which every participant was same day procedure to discharge.', 'description': "Defined as the overall rate of the catheter's procedure kit component complications from time of procedure to discharge.", 'unitOfMeasure': 'Kit Component Complications', 'reportingStatus': 'POSTED', 'populationDescription': 'No data was collected out to the timepoints following 1-month due to early study termination.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Pristine™ Long-Term Hemodialysis Catheter', 'description': 'The Pristine™ Long-Term Hemodialysis Catheter is a chronic hemodialysis catheter consisting of a dual lumen radiopaque shaft with a pre-formed split tip, which enables long-term vascular access for hemodialysis. The device is intended to be used in patients suffering from chronic kidney disease. The Pristine™ Catheter will be placed according to the Instructions for Use (IFU).\n\nPristine™ Long-Term Hemodialysis Catheter: Placement of the Pristine™ Long-Term Hemodialysis Catheter Placement.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}]}, {'type': '1-Month Follow-up', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': '3-Month Follow-up', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}, {'type': '6-Month Follow-up', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}, {'type': '12-Month Follow-up', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}]}], 'dropWithdraws': [{'type': 'Investigation Early Termination by Sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Arteriovenous-fistula mature', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Pristine™ Long-Term Hemodialysis Catheter', 'description': 'The Pristine™ Long-Term Hemodialysis Catheter is a chronic hemodialysis catheter consisting of a dual lumen radiopaque shaft with a pre-formed split tip, which enables long-term vascular access for hemodialysis. The device is intended to be used in patients suffering from chronic kidney disease. The Pristine™ Catheter will be placed according to the Instructions for Use (IFU).\n\nPristine™ Long-Term Hemodialysis Catheter: Placement of the Pristine™ Long-Term Hemodialysis Catheter Placement.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '7', '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': '1', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '1', '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': '7', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-02-04', 'size': 2758072, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_002.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-02-02T14:13', 'hasProtocol': True}, {'date': '2022-07-18', 'size': 881208, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-12-19T16:49', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 142}}, 'statusModule': {'whyStopped': 'Terminated due to considerable changes in the clinical landscape post Covid-19, leading to difficulties executing the study. Results were blinded at time of termination.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2022-05-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2022-09-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-15', 'studyFirstSubmitDate': '2022-01-27', 'resultsFirstSubmitDate': '2023-12-20', 'studyFirstSubmitQcDate': '2022-01-27', 'lastUpdatePostDateStruct': {'date': '2024-04-11', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-03-15', 'studyFirstPostDateStruct': {'date': '2022-02-08', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-04-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Kit Component Safety and Performance', 'timeFrame': 'From Index Procedure to Discharge, of which every participant was same day procedure to discharge.', 'description': "Defined as the overall rate of the catheter's procedure kit component complications from time of procedure to discharge."}], 'primaryOutcomes': [{'measure': 'Overall Complication Rate of the Pristine™ Catheter', 'timeFrame': 'At 3 months post index procedure.', 'description': 'The combined Primary Endpoint is the overall rate of infectious complications and non-infectious complications requiring revision to maintain patency and improve access performance, evaluated against a performance goal (PG) derived from the Dialysis Outcomes and Practice Patterns Study (DOPPS) data.'}], 'secondaryOutcomes': [{'measure': 'Rate of Freedom From Catheter-related Bloodstream Infection (CRBSI)', 'timeFrame': '1-month Post-Index Procedure.', 'description': '2019 KDOQI Guidelines for CRBSI defined as, clinical manifestations and at least 1 positive blood culture result from a peripheral source (dialysis circuit or vein) and no other apparent source, with either positive semiquantitative (\\>15 CFU/catheter segment, hub or tip) or quantitative (\\>102 CFU/catheter segment, eg, hub or tip) culture, whereby the same organism (species and antibiogram) is isolated from the catheter segment (eg, hub or tip) and a peripheral source (dialysis circuit or vein) blood sample.'}, {'measure': 'Rate of Freedom From Device and/or Procedure-related Adverse Events', 'timeFrame': '1-month Post-Index Procedure.', 'description': 'Number of participants free from Device and/or Procedure-related adverse events.'}, {'measure': 'Rate of Technical Success', 'timeFrame': 'At time of Index Procedure.', 'description': 'Number of Participants with successful placement of the Pristine™ Long-Term Hemodialysis Catheter'}, {'measure': 'Overall Participant Survival Rate', 'timeFrame': '1-month Post-Index Procedure.', 'description': 'Number of participants that have not died from any catheter related complication.'}, {'measure': 'Overall Catheter Survival Rate', 'timeFrame': '1-month Post-Index Procedure', 'description': 'Number of participants with whom the Pristine™ Catheters have not been removed for any cause.'}, {'measure': 'Overall Patency Rate', 'timeFrame': '1-month Post-Index Procedure', 'description': 'Number of participants with their Pristine™ catheter having the ability to achieve a mean dialysis blood flow of ≥300mL/min without need for additional interventions.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Kidney Replacement Therapy', 'Hemodialysis', 'Vascular Access'], 'conditions': ['Kidney Failure, Chronic', 'Hemodialysis Complication', 'Hemodialysis Catheter Infection', 'Hemodialysis Access Failure', 'Central Venous Catheter Related Bloodstream Infection', 'End Stage Renal Disease']}, 'descriptionModule': {'briefSummary': 'This is a prospective, multi-center, single-arm study designed to assess the safety and performance of the Pristine™ Long-Term Hemodialysis Catheter.', 'detailedDescription': 'A total of 142 patients will be enrolled and have the Pristine™ Long-Term Hemodialysis Catheter placed. Under the current enrollment assumptions, up to 15 investigational sites in the United States (US) will participate. Eligible participants will have End Stage Renal Disease requiring hemodialysis through a tunneled dialysis catheter. Follow-up for all enrolled participants will be performed at 1-month, 3-months, 6-months, and 12-months post-Index Procedure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. The participant or legally designated representative must voluntarily sign and date the approved Informed Consent Form (ICF) prior to collection of study-specific data or performance of study-specific procedures.\n2. The participant must be willing and able to comply with protocol requirements, including all study visits and procedures.\n3. The participant must be either a male or non-pregnant female ≥18 years of age.\n4. The participant must have a diagnosis of End Stage Renal Disease with indication for a tunneled dialysis catheter creation.\n5. Participant must require chronic hemodialysis treatments 3 times per week with intended use of the Pristine™ Long-Term Hemodialysis Catheter.\n6. The participant meets the indications for hemodialysis use and does not meet any of the contraindications per the Pristine Instructions for Use (IFU).\n7. The participant must have a patent jugular vein or subclavian vein.\n\nExclusion Criteria:\n\n1. The participant has known central venous stenosis\n2. Based on the local primary investigator's discretion, the patient would not be an appropriate study candidate.\n3. The participant has already undergone an AVF or AVG procedure and is awaiting maturation.\n4. The participant has an active infection at the time of study enrollment.\n5. The participant has a presence of bacteremia or infection within 7 days prior to enrollment.\n6. The participant has a history neutropenia or a history of severe immunodeficiency disease.\n7. The participant has uncontrolled abnormal coagulation parameters and are at additional risk for clotting or excessive bleeding at time of enrollment per physicians opinion.\n8. The participant has a known allergy, intolerance or sensitivity to heparin, or previous incidence of heparin-induced thrombocytopenia.\n9. The participant has a known allergy or hypersensitivity to any of the device materials or Ethylene oxide (EtO).\n10. The participant has another medical condition or treatment, which in the opinion of the investigator, the participant may be non-compliant with the protocol, confound the data interpretation, or is associated with a life expectancy insufficient to allow for completion of study procedures and follow-up.\n11. The participant is currently participating in an investigational drug or another device study that has not completed the study treatment or that clinically interferes with the study endpoints. Note: Studies requiring extended follow-up visits for products that were investigational but have since become commercially available, are not considered investigational studies."}, 'identificationModule': {'nctId': 'NCT05228132', 'briefTitle': 'The Pristine Post-Market Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'C. R. Bard'}, 'officialTitle': 'A Prospective, Multi-Center, Single-Arm Clinical Study of the Pristine™ Long-Term Hemodialysis Catheter', 'orgStudyIdInfo': {'id': 'BDPI-21-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pristine™ Long-Term Hemodialysis Catheter', 'description': 'The Pristine™ Long-Term Hemodialysis Catheter is a chronic hemodialysis catheter consisting of a dual lumen radiopaque shaft with a pre-formed split tip, which enables long-term vascular access for hemodialysis. The device is intended to be used in patients suffering from chronic kidney disease. The Pristine™ Catheter will be placed according to the Instructions for Use (IFU).', 'interventionNames': ['Device: Pristine™ Long-Term Hemodialysis Catheter']}], 'interventions': [{'name': 'Pristine™ Long-Term Hemodialysis Catheter', 'type': 'DEVICE', 'description': 'Placement of the Pristine™ Long-Term Hemodialysis Catheter Placement.', 'armGroupLabels': ['Pristine™ Long-Term Hemodialysis Catheter']}]}, 'contactsLocationsModule': {'locations': [{'zip': '36301', 'city': 'Dothan', 'state': 'Alabama', 'country': 'United States', 'facility': 'Trinity Research Group LLC', 'geoPoint': {'lat': 31.22323, 'lon': -85.39049}}, {'zip': '06520', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Yale University', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '71103', 'city': 'Shreveport', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Louisiana State University Health Shreveport Medical Center', 'geoPoint': {'lat': 32.52515, 'lon': -93.75018}}, {'zip': '48202', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Henry Ford Health System', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '27610', 'city': 'Raleigh', 'state': 'North Carolina', 'country': 'United States', 'facility': 'North Carolina Nephrology, PA', 'geoPoint': {'lat': 35.7721, 'lon': -78.63861}}, {'zip': '02906', 'city': 'Providence', 'state': 'Rhode Island', 'country': 'United States', 'facility': 'JML Research Associates', 'geoPoint': {'lat': 41.82399, 'lon': -71.41283}}], 'overallOfficials': [{'name': 'Jeffrey Hoggard, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Raleigh Access Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'C. R. Bard', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}