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

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

Status

Withdrawn

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04782297

Acronym

LTHD PMCF

Enrollment

Registered

2021-03-04

Start date

2022-03-30

Completion date

2023-03-17

Last updated

2024-01-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

CKD, ESRD

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.

Interventions

DEVICELong term hemodialysis catheter

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

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame	Description
Insertion Success	Percentage at Insertion	Successful initiation of vascular access device insertion, as determined by the investigator.

Secondary

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

Countries

Spain, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026