Long Term Hemodialysis Catheters (LTHD) Post Market Clinical Follow up (PMCF)

Medical Components, Inc dba MedComp

Overview

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.

Study Type

OBSERVATIONAL

Conditions

CKD ESRD

Interventions

Long term hemodialysis catheterDEVICE

There will be no interventions in this study. Strictly observational.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. ≥ 18 years of age at the time of enrollment 2. Patients who have previously received the Medcomp subject device or patients currently receiving hemodialysis treatment, who have had a Medcomp subject device implanted for \>90 days 3. 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) 4. Subject or authorized representative participated in the Informed Consent process and signed/dated the relevant institutional ethics committee approved Informed Consent form Exclusion Criteria: 1. Meet any of the contraindications listed on the Medcomp Long Term Hemodialysis Catheter Instructions for Use 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)

Locations (2)

University of Maryland School of Medicine Vascular & Interventional Radiology Department

Baltimore, Maryland, United States

Hospital Universitari Arnau de Vilanova

Lleida, Spain

Outcomes

Primary Outcomes

Insertion Success

Successful initiation of vascular access device insertion, as determined by the investigator.

Time frame: Percentage at Insertion

Secondary Outcomes

Adverse Events (Infection per 1000 catheter days)

Infection, Removals due to infection or thrombosis, catheter related blood stream infection (CRBSI)

Time frame: 1000 catheter days

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.