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

ESRD Clinical Trial

Official title:
Post-Market Clinical Follow-up Study - Open Label, Consecutive Series, Observational Study on the Use of Medcomp Long Term Catheters for Hemodialysis (LTHD)

Clinical Trial 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.

Clinical Trial Description

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 Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04782297
Study type Observational
Source Medical Components, Inc dba MedComp
Contact
Status Withdrawn
Phase
Start date March 30, 2022
Completion date March 17, 2023
View Details
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