LTHD PMCF: Long Term Hemodialysis Catheters (LTHD) Post Market Clinical Follow up (PMCF)
Study Details
Study Description
Brief Summary
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.
Detailed Description
Open Label, Consecutive Series, Observational cohort study of patients using Medcomp LTHD catheters. Prospective and retrospective patients will be enrolled. The study will include patients in the EU who are receiving or have received one of the three subject Medcomp LTHD Catheters as their initial HD catheter. The data available and summarized for these products are considered sufficient to determine if undesirable side effects exist for the subject device and conclude that the device conforms to the requirement on acceptability of side effects (2017/745 MDR GSPR Annex 1). Additionally, the benefits of the subject devices outweigh the risks, and it can be concluded that the devices conform to the requirement on acceptable benefit/ risk profile (2017/745 MDR GSPR Annex 1).
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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. |
Device: Long term hemodialysis catheter
There will be no interventions in this study. Strictly observational.
|
| 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 |
Device: Long term hemodialysis catheter
There will be no interventions in this study. Strictly observational.
|
| Hemo-Cath LT Catheter The Hemo-Cath® LT Catheter is designed for continuous extraction of a patient's blood and reinfusion of filtered blood. It has two lumens: the arterial lumen is utilized to withdraw blood from the patient and the venous lumen returns the blood to the patient after treatment. In order to increase filtering efficiency, the tip of the extraction ("inflow") lumen is separated from the reinfusion ("outflow") lumen, minimizing the reentry of dialyzed blood from the venous return into the arterial inflow ("recirculation"). This separation is achieved with a step-tip design. |
Device: Long term hemodialysis catheter
There will be no interventions in this study. Strictly observational.
|
Outcome Measures
Primary Outcome Measures
- Adequacy of flow rate [time period between catheter implantation for a minimum periof of 90 days or until removal for any reason which ever comes first]
Primary catheter patency
Secondary Outcome Measures
- Adverse Events (Infection per 1000 catheter days) [1000 catheter days]
Infection, Removals due to infection or thrombosis, catheter related blood stream infection (CRBSI)
Eligibility Criteria
Criteria
Inclusion Criteria:
-
- ≥ 18 years of age at the time of enrollment 2. Received, currently, receiving or plan to receive hemodialysis treatment within 30 days 3. Must be patient's initial catheter. (retrospective or prospective) 4. Receiving or have received a Medcomp LTHD Catheter subject of this study (refer to Section 2) 5. Health records relevant to this study are complete and accessible by Study team at the hemodialysis center, implantation center, medical facilities where complications are treated, and by the participating Principal Investigator (PI) 6. Subject or authorized representative participated in the Informed Consent process and signed/dated the relevant institutional ethics committee approved Informed Consent form
Exclusion Criteria:
- Meet any of the contraindications listed on the Medcomp Long Term Hemodialysis Catheter Instructions for Use (Appendix A) 2. Participation in any other drug, device, or biologic study concomitantly, or within the last 30 days (which may clinically interfere with this Study in the opinion of the sponsor in consultation with the Principal Investigator) 3. Hemodialysis treatment expected to last < 90 days from time of catheter implantation 4. Life expectancy of <90 days post catheter implantation 5. Coagulopathy defined as international normalized ratio (INR) >2 which cannot be corrected 6. Patients who are receiving anti-coagulant and/or anti-platelet medication who cannot be managed according to the SIR 2019 consensus guidelines and/or where there is a platelet count <50,000/microliter Patients who are immunosuppressed either by medication (including use of high-dose corticosteroids) or disease processes other than ESRD itself 8. Active infection(s) in any location <30 days prior to enrollment.
- Presence of bacteremia or infected AVG/AVF within 7 days prior to enrollment 10. Neutropenia defined as absolute neutrophil count less than 1,700/microliter 11. Pregnant or nursing patients or those planning to become pregnant during the study period 12. Patients in whom the catheter placement is otherwise contraindicated based upon investigator assessment
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Medical Components, Inc dba MedComp
- Syneos Health
- Veeva Systems
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- PMCF_LTHD_201