Recruitment and enrollment was not prioritized by sites and no enrollments occurred over the course of 1 year.
LTHD PMCF
Post-Market Clinical Follow-up Study - Open Label, Consecutive Series, Observational Study on the Use of Medcomp Long Term Catheters for Hemodialysis (LTHD)
Sponsor study identifier
observational
0
2 countries
2
Study Start
March 30, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
March 17, 2023
Actual (reported)Study Completion
March 17, 2023
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 17, 2023
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 2, 2021
Actual (reported)March 4, 2021
Actual (reported)March 30, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
March 17, 2023
Actual (reported)March 17, 2023
Actual (reported)Insertion Success
Successful initiation of vascular access device insertion, as determined by the investigator.
Percentage at Insertion
Adverse Events (Infection per 1000 catheter days)
1000 catheter days
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.
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
There will be no interventions in this study. Strictly observational.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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.
University of Maryland School of Medicine Vascular & Interventional Radiology Department
Baltimore, Maryland, 21202, United States
Hospital Universitari Arnau de Vilanova
Lleida, 25198, Spain
0 participants (actual enrollment reported by the registry).
First Submitted
March 2, 2021
First Posted
March 4, 2021
Study Start
March 30, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
An Open Label Study to Allow Patients Continuous Use of the HemoCare™ Hemodialysis System
Contact the study team to confirm eligibility.
Primary Completion
March 17, 2023
Actual (reported)Study Completion
March 17, 2023
Actual (reported)Last Updated
January 10, 2024
Record last verified: 2024-01
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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