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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2022-03-30

Study Completion Date

2023-03-17

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Renal Denervation in Patients With Chronic Heart Failure & Renal Impairment Clinical Trial

NCT01392196

Heart Failure

TERMINATED NA

Exploratory Study to Explore the Safety and Efficacy of the HDx Therapy Using Theranova 500 Dialyzer in Comparison to Hemodiafiltration

NCT03499691

End Stage Renal Disease

COMPLETED NA

Evaluation of Biocompatibility and Performances of 4 Dialyzers in Different Mode Treatments

NCT03262272

End Stage Renal Disease Inflammation

COMPLETED NA

Comparison of MCO HD on Markers of Vascular Health Compared With On-Line Haemodiafiltration

NCT03510520

End Stage Renal Disease Cardiovascular Diseases Inflammation

COMPLETED NA

Comparing Hemodiafiltration with and Without Hemoadsorption

NCT06710834

Hemodialysis Hemodiafiltration Hemoadsorption

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

CKD ESRD

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Long term hemodialysis catheter

Intervention Type DEVICE

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

Long term hemodialysis catheter

Intervention Type DEVICE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Long term hemodialysis catheter

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

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No