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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.
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This is a prospective, multi-center, single-arm study designed to assess the safety and performance of the Pristineâ„¢ Long-Term Hemodialysis Catheter.
A total of 142 patients will be enrolled and have the Pristineâ„¢ 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pristineâ„¢ Long-Term Hemodialysis Catheter | Experimental | The Pristineâ„¢ 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 Pristineâ„¢ Catheter will be placed according to the Instructions for Use (IFU). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pristineâ„¢ Long-Term Hemodialysis Catheter | Device | Placement of the Pristineâ„¢ Long-Term Hemodialysis Catheter Placement. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Complication Rate of the Pristineâ„¢ Catheter | 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. | At 3 months post index procedure. |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Freedom From Catheter-related Bloodstream Infection (CRBSI) | 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 | Description | Time Frame |
|---|---|---|
| Kit Component Safety and Performance | Defined as the overall rate of the catheter's procedure kit component complications from time of procedure to discharge. | From Index Procedure to Discharge, of which every participant was same day procedure to discharge. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeffrey Hoggard, MD | Raleigh Access Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Trinity Research Group LLC | Dothan | Alabama | 36301 | United States | ||
| Yale University |
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| ID | Title | Description |
|---|---|---|
| FG000 | Pristineâ„¢ Long-Term Hemodialysis Catheter | The Pristineâ„¢ 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 Pristineâ„¢ Catheter will be placed according to the Instructions for Use (IFU). Pristineâ„¢ Long-Term Hemodialysis Catheter: Placement of the Pristineâ„¢ Long-Term Hemodialysis Catheter Placement. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 4, 2022 | Feb 2, 2024 |
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| 1-month Post-Index Procedure. |
| Rate of Freedom From Device and/or Procedure-related Adverse Events | Number of participants free from Device and/or Procedure-related adverse events. | 1-month Post-Index Procedure. |
| Rate of Technical Success | Number of Participants with successful placement of the Pristineâ„¢ Long-Term Hemodialysis Catheter | At time of Index Procedure. |
| Overall Participant Survival Rate | Number of participants that have not died from any catheter related complication. | 1-month Post-Index Procedure. |
| Overall Catheter Survival Rate | Number of participants with whom the Pristineâ„¢ Catheters have not been removed for any cause. | 1-month Post-Index Procedure |
| Overall Patency Rate | 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. | 1-month Post-Index Procedure |
| New Haven |
| Connecticut |
| 06520 |
| United States |
| Louisiana State University Health Shreveport Medical Center | Shreveport | Louisiana | 71103 | United States |
| Henry Ford Health System | Detroit | Michigan | 48202 | United States |
| North Carolina Nephrology, PA | Raleigh | North Carolina | 27610 | United States |
| JML Research Associates | Providence | Rhode Island | 02906 | United States |
| 1-Month Follow-up |
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| 3-Month Follow-up |
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| 6-Month Follow-up |
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| 12-Month Follow-up |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Pristineâ„¢ Long-Term Hemodialysis Catheter | The Pristineâ„¢ 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 Pristineâ„¢ Catheter will be placed according to the Instructions for Use (IFU). Pristineâ„¢ Long-Term Hemodialysis Catheter: Placement of the Pristineâ„¢ Long-Term Hemodialysis Catheter Placement. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Overall Complication Rate of the Pristineâ„¢ Catheter | 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. | 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. | Posted | At 3 months post index procedure. |
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| Secondary | Rate of Freedom From Catheter-related Bloodstream Infection (CRBSI) | 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. | No data was collected out to the timepoints following 1-month due to early study termination. | Posted | Count of Participants | Participants | No | 1-month Post-Index Procedure. |
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| Secondary | Rate of Freedom From Device and/or Procedure-related Adverse Events | Number of participants free from Device and/or Procedure-related adverse events. | No data was collected out to the timepoints following 1-month due to early study termination. | Posted | Count of Participants | Participants | No | 1-month Post-Index Procedure. |
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| Secondary | Rate of Technical Success | Number of Participants with successful placement of the Pristineâ„¢ Long-Term Hemodialysis Catheter | No data was collected out to the timepoints following 1-month due to early study termination. | Posted | Count of Participants | Participants | At time of Index Procedure. |
|
| |||||||||||||||||
| Secondary | Overall Participant Survival Rate | Number of participants that have not died from any catheter related complication. | No data was collected out to the timepoints following 1-month due to early study termination. | Posted | Count of Participants | Participants | No | 1-month Post-Index Procedure. |
|
| ||||||||||||||||
| Secondary | Overall Catheter Survival Rate | Number of participants with whom the Pristineâ„¢ Catheters have not been removed for any cause. | No data was collected out to the timepoints following 1-month due to early study termination. | Posted | Count of Participants | Participants | No | 1-month Post-Index Procedure |
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| ||||||||||||||||
| Secondary | Overall Patency Rate | 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. | No data was collected out to the timepoints following 1-month due to early study termination. | Posted | Count of Participants | Participants | No | 1-month Post-Index Procedure |
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| Other Pre-specified | Kit Component Safety and Performance | Defined as the overall rate of the catheter's procedure kit component complications from time of procedure to discharge. | No data was collected out to the timepoints following 1-month due to early study termination. | Posted | Number | Kit Component Complications | From Index Procedure to Discharge, of which every participant was same day procedure to discharge. |
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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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pristineâ„¢ Long-Term Hemodialysis Catheter | The Pristineâ„¢ 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 Pristineâ„¢ Catheter will be placed according to the Instructions for Use (IFU). Pristineâ„¢ Long-Term Hemodialysis Catheter: Placement of the Pristineâ„¢ Long-Term Hemodialysis Catheter Placement. | 0 | 7 | 3 | 7 | 2 | 7 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Not Device Related-Septic Shock | Infections and infestations | Non-systematic Assessment | Sepsis - bacteraemia, viraemia and fungaemia - Day 17 - Not Related to Device or Procedure |
| |
| Device Related-Thrombosis in device | Product Issues | Non-systematic Assessment | Thrombosis in device - Clotted Catheter - Day 55 - Likely device related, Unlikely procedure related |
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| Device Related-Thrombosis in device | Product Issues | Non-systematic Assessment | Thrombosis in device - Clotted Catheter - Day 20 - Likely device related, Not procedure related |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Procedural pain | Injury, poisoning and procedural complications | Non-systematic Assessment | Procedural Pain - Acute Post-Op Pain - Day 0 - Not device related, Likely procedure related |
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| Dizziness | Nervous system disorders | Non-systematic Assessment | Dizziness - Day 40 - Not procedure or device related |
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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.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Joshua Black, Clinical Project Manager | Becton Dickinson | 520-599-6124 | joshua.black@bd.com |
| Prot_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 18, 2022 | Dec 19, 2023 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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