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

NCT04782297 | Withdrawn FDA Device

• 1 other identifier: PMCF_LTHD_201
• Study Type: observational
• Target: N/A
• Locations: 2 countries
• Sites: 2

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.

Conditions

CKD; ESRD

Outcome Measures

Primary Outcomes (1)

• Insertion Success

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

  Percentage at Insertion

Secondary Outcomes (1)

• Adverse Events (Infection per 1000 catheter days)

  1000 catheter days

Study Arms (2)

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.

Device: Long term hemodialysis catheter

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

Device: Long term hemodialysis catheter

Interventions

Long term hemodialysis catheter DEVICE

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

Hemo-Flow Catheter; Titan HD Catheter

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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.

You may qualify if:

• ≥ 18 years of age at the time of enrollment
• 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
• 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)
• Subject or authorized representative participated in the Informed Consent process and signed/dated the relevant institutional ethics committee approved Informed Consent form

You may not qualify if:

• Meet any of the contraindications listed on the Medcomp Long Term Hemodialysis Catheter Instructions for Use
• 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)

Sponsors & Collaborators

• Medical Components, Inc dba MedComp: lead
• Syneos Health: collaborator
• Veeva Systems: collaborator

Study Sites (2)

University of Maryland School of Medicine Vascular & Interventional Radiology Department

Baltimore, Maryland, 21202, United States

Location

Hospital Universitari Arnau de Vilanova

Lleida, 25198, Spain

Location

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2021
• First Posted: March 4, 2021
• Study Start: March 30, 2022
• Primary Completion: March 17, 2023
• Study Completion: March 17, 2023
• Last Updated: January 10, 2024

Record last verified: 2024-01

Locations

US (1); ES (1)