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

Withdrawn before enrolling

Conditions studied: CKD, ESRD

In brief

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.

Key facts

Study ID

NCT04782297

Run by

Medical Components, Inc dba MedComp

People needed

0

Starts

2022-03-30

Expected to finish

2023-03-17

Last updated by the study team

2024-01-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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)

Where it is running

• University of Maryland School of Medicine Vascular & Interventional Radiology Department — Baltimore, Maryland, United States
• Hospital Universitari Arnau de Vilanova — Lleida, Spain

Full record on ClinicalTrials.gov

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