TerminatedNot Applicable

BONE ANCHORED PORT for Hemodialysis Treatment

Switzerland6 participantsStarted 2016-04-04

Plain-language summary

A Bone Anchored Port System (BAP) will be implanted in the mastoid bone behind the ear, connected with a double lumen central venous catheter inserted in the jugular vein, and will be used in conjunction with an adapter as a permanent vascular access for hemodialysis treatment.

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.

Exclusion criteria

. Clinical contraindications for the implantation of a BAP including:
. Life expectancy less than 1 year from the time of enrolment in the study.
. Expected transplantation within the intended study duration (i.e. known living donor).
. Pregnancy or breast feeding.
. Women of childbearing potential without appropriate contraceptive method.
. Patient known to be HIV, hepatitis C or hepatitis B antigen positive.
. Any form of substance abuse, psychiatric disorder or condition which, in the opinion of the investigator may complicate communication with the investigator.
. Participation in another clinical study (medicinal, medical device) within the last 30 days.

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

Device survival probability after one year

Timeframe: up to 12 months after Study start

Trial details

NCT IDNCT02069860

SponsorCendres+Métaux

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2019-12-23

View on ClinicalTrials.gov More End-Stage Renal Disease Requiring Haemodialysis trials