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 range18 Years

SexALL

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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.

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