WithdrawnNot Applicable

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

Stopped: Recruitment and enrollment was not prioritized by sites and no enrollments occurred over the course of 1 year.

United States, Spain0Started 2022-03-30

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. ≥ 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

Exclusion criteria

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Insertion Success

Timeframe: Percentage at Insertion

Trial details

NCT IDNCT04782297

SponsorMedical Components, Inc dba MedComp

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2023-03-17

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