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Recruitment and enrollment was not prioritized by sites and no enrollments occurred over the course of 1 year.
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| Name | Class |
|---|---|
| Syneos Health | OTHER |
| Veeva Systems | INDUSTRY |
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The primary objective of this observational PMCF study is to collect clinical data on the safety and efficacy of Medcomp Long Term Hemodialysis (LTHD) Catheter Kits in compliance with MDR 2017/745.
The Observational Study will enroll a target of 198 subjects across two cohorts of 89 patients per cohort, with each cohort representing one catheter type. Retrospective patients previously treated with either a Hemo-Flow or Titan HD catheter will be enrolled. The primary endpoint of this study for all device families is insertion success. For the purposes of this data, a successful insertion will be defined as the successful initiation of vascular access device insertion, as determined by the investigator.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Titan HD Catheter | The Titan HD Catheter is a double lumen catheter that provides 2 dedicated (arterial/venous) access lumens. Each lumen is connected through an extension line with female luer connectors. The arterial and venous catheter lumens connect to a hub to facilitate connection of extension tubes with clamps intended to prevent air/fluid communication and control fluid flow through the catheter. At the proximal end of the extension tubes are female Luer fittings to provide a needleless connection. The clamps and the sleeves are color-coded red for the arterial lumen and blue for the venous lumen. Each catheter has a cuff which is intended to be positioned underneath the skin at the skin exit to aid in securing the catheter and to provide a barrier to minimize the risk of infection. Each lumen is connected through an extension line with female Luer connectors. The transition between lumen and extension is housed within a molded hub. |
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| Hemo-Flow Catheter | The Hemo-Flow® Catheter has two lumens (one arterial lumen, one venous lumen) comprised of a biocompatible polymeric material that contains radiopaque filler to allow radiographic imaging of the distal tips to ensure proper placement into the superior vena cava. The arterial lumen is utilized to withdraw blood from the patient and the venous lumen returns the blood to the patient after treatment |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Long term hemodialysis catheter | Device | There will be no interventions in this study. Strictly observational. |
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| Measure | Description | Time Frame |
|---|---|---|
| Insertion Success | Successful initiation of vascular access device insertion, as determined by the investigator. | Percentage at Insertion |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events (Infection per 1000 catheter days) | Infection, Removals due to infection or thrombosis, catheter related blood stream infection (CRBSI) | 1000 catheter days |
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Inclusion Criteria:
Exclusion Criteria:
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Retrospective patients (those who already have one of the Medcomp LTHD catheters inserted) will be enrolled. Retrospective patients from the previous 36 months will be approached for participation in the study. Patients who have previously received a Medcomp LTHD catheter will also be approached for consent and assessment of eligibility.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Maryland School of Medicine Vascular & Interventional Radiology Department | Baltimore | Maryland | 21202 | United States | ||
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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 |
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| Hospital Universitari Arnau de Vilanova |
| Lleida |
| 25198 |
| Spain |
| 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 |