BONE ANCHORED PORT for Hemodialysis Treatment

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 conjunct...

Lead sponsor: Cendres+Métaux•1 locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

Cendres+Métaux

STUDY OBJECTIVE The objective of the clinical investigation is to demonstrate feasibility regarding safety, efficiency and clinical performance of the BAP as a permanent access for chronic haemodialysis therapy in patients with renal failure to reach the certificate European (CE) mark and conduct a post market follow-up study. PRIMARY ENDPOINT 1\) Device survival probability after one year (product - limit estimator of Kaplan-Meier Analysis). An event is the primary failure of BAP, defined by necessity to remove the device: for any medical reason (e.g. infections at wound or mastoid, thrombosis, and severe patient discomfort) SECONDARY ENDPOINTS 1. Performance - Implantation and primary healing process * Failure to implant a device due to procedural complications or unforeseen anatomical reasons, except for intra-operatively detected exclusion criteria * Successful attempt on the site contralateral to the planned side * Duration of the implantation procedure measured from incision to final suture * Duration of hospitalization before implantation / after implantation * Time from implantation to first use for haemodialysis * Rate of patients with complications stratified by * Dura mater exposed / injured * Blood sinus injured * Injury of facial nerve * Carotid artery puncture * Central vein perforation * Bleeding, defined as requirement for blood products * Pneumothorax * Hematothorax * Initial healing and stabilization of BAP, Infections at implantation site * Septicaemias with no other source of infection than surgical-procedures impairment for mechanical reasons 2. Performance - removal of catheter * Failure to provide a blood flow ≥200ml/min for more than 2 consecutive weeks * Catheter related and untreatable infection * Surgical or interventional (Seldinger technique) procedure * Persistent recirculation higher than 15% 3. Performance - Dialysis use * Average blood flow rate * Average venous pressure * Average arterial pressure * Recirculation * Volume-corrected clearance (Kt/V) * Access thrombosis reversible by non-surgical means * Infections of any kind * in anatomical structures around implant * remote infections possibly related to the BAP * bacteriemia/septicemia 4. Design Validation * Questionnaire for the implantation surgeon * Questionnaire for the dialysis staff * Questionnaire for patients * Quality of Life (QoL) Questionnaire (EQ-5D) * Questionnaire for change / removal of catheter

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: November 21, 2022Terms

Trial snapshot

StatusTERMINATED

PhaseNA

Enrollment6

Start dateApr 2016

Last updatedNov 21, 2022

Condition

End-Stage Renal Disease Requiring Haemodialysis Hemodialysis Access Failure (Disorder)

Locations shown

Inselspital Bern

Bern

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 21, 2022Data synced to Clareo: June 28, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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