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

Withdrawn

• Conditions: CKD; ESRD
• Interventions: Device: Long term hemodialysis catheter

• Registration Number: NCT04782297
• Lead Sponsor: Medical Components, Inc dba MedComp

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

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 Timeline

• Study First Submitted: 2021-03-02
• Study First Submitted QC: 2021-03-03
• Study First Posted: 2021-03-04
• Study Start: 2022-03-30
• Primary Completion: 2023-03-17
• Study Completion: 2023-03-17
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-08
• Last Update Posted: 2024-01-10

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Titan HD Catheter	Long term hemodialysis 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.
Hemo-Flow Catheter	Long term hemodialysis 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

Primary Outcome Measures

Name	Time	Method
Insertion Success	Percentage at Insertion	Successful initiation of vascular access device insertion, as determined by the investigator.

Secondary Outcome Measures

Name	Time	Method
Adverse Events (Infection per 1000 catheter days)	1000 catheter days	Infection, Removals due to infection or thrombosis, catheter related blood stream infection (CRBSI)

Trial Locations

Locations (2)

University of Maryland School of Medicine Vascular & Interventional Radiology Department; 🇺🇸 Baltimore, Maryland, United States

Hospital Universitari Arnau de Vilanova; 🇪🇸 Lleida, Spain