BONE ANCHORED PORT for Hemodialysis Treatment (BAP)

Bone Anchored Port - a Novel Vascular Access 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 conjunction with an adapter as a permanent vascular access for hemodialysis treatment.

Study Overview

• Status: Terminated
• Conditions: Hemodialysis Access Failure (Disorder); End-Stage Renal Disease Requiring Haemodialysis
• Intervention / Treatment: Device: Bone Anchored Port System (BAP)

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Bern, Switzerland, 3010
    • Inselspital Bern

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Indication for a permanent haemodialysis access
• Impossibility to construct or revise an AC-Fistula
• Age > 18 years.
• Written, informed consent.
• Availability of vascular imaging of the jugular vein at the implantation site with no contraindication for a jugular vein catheter

Exclusion Criteria:

1. Clinical contraindications for the implantation of a BAP including:

   • known intolerance to any of the BAP materials

   • ongoing infections e.g.

     • mastoiditis / otitis media
     • skin infection in the area of presumed implantation-site
     • generalized acute and chronic infections
   • severe skin lesions (e.g. dermatitis, psoriasis) in the area of the presumed implantation site
   • previous surgery at the petrous bone
   • deafness
   • known significant bleeding disorder
   • known thrombophilia
2. Life expectancy less than 1 year from the time of enrolment in the study.
3. Expected transplantation within the intended study duration (i.e. known living donor).
4. Pregnancy or breast feeding.
5. Women of childbearing potential without appropriate contraceptive method.
6. Patient known to be HIV, hepatitis C or hepatitis B antigen positive.
7. Any form of substance abuse, psychiatric disorder or condition which, in the opinion of the investigator may complicate communication with the investigator.
8. Participation in another clinical study (medicinal, medical device) within the last 30 days.
9. Multiple participation of one subject in this clinical investigation.
10. Inability to understand German and to give written informed consent.
11. Patients suffering from epilepsy, addiction or other condition resulting in a higher risk of falling.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: Access for heamodialysis treatment; The 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

Device: Bone Anchored Port System (BAP); The port body will be implanted onto the petrous bone and a sealing cap, a twofold valve system and a catheter are connected to the port body. The catheter is tunneled under the skin, enters the internal jugular vein and ends in the right atrium of the heart. The novelty of the access lies in its location (retro auricular on petrous bone) and its bone fixation.; Other Names: Retroauricular anchored devices; Permanent central venous vascular access devices; Tunneled catheters; BAHA and Jarvik 2000 pedestal

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Device survival probability after one year	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).	up to 12 months after Study start

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 byDura mater exposed / injuredBlood sinus injuredInjury of facial nerveCarotid artery punctureCentral vein perforationBleeding, defined as requirement for blood productsPneumothoraxHematothorax; Initial healing and stabilization of BAP, Infections at implantation site; Septicaemias with no other source of infection than surgical-procedures impairment for mechanical reasons	up to 18 months after Study start

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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%	up to 18 months after Study start
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 kindin anatomical structures around implant (skin: Holgers' Classification System)in portin catheterremote infections possibly related to the BAPbacteriemia/septicemia	up to 18 months after Study start
Design Validation	Usability implantation tools & procedure; Assessment dialysis staff / Problems during dialysis; Daily life with BAP; Patient health status (Questionnaire EQ-5D); Feasibility of catheter change / removal	up to 18 months after Study start

Collaborators and Investigators

• Sponsor: Cendres+Métaux
• Investigators: Principal Investigator: Uehlinger Dominik, Prof. Dr. med., University Hospital, Inselspital, Berne, Switzerland

Publications and helpful links

General Publications

• Stieger C, Arnold A, Kruse A, Wiedmer S, Widmer M, Guignard J, Schutz D, Guenat JM, Bachtler M, Caversaccio M, Uehlinger DE, Frey FJ, Hausler R. Novel Bone-Anchored Vascular Access on the Mastoid for Hemodialysis: Concept and Preclinical Trials. IEEE Trans Biomed Eng. 2016 May;63(5):984-990. doi: 10.1109/TBME.2015.2480241. Epub 2015 Sep 18.
• Caversaccio M, Wimmer W, Widmer M, Bachtler M, Kalicki R, Uehlinger D, Arnold A. A novel retroauricular fixed port for hemodialysis: surgical procedure and preliminary results of the clinical investigation. Acta Otolaryngol. 2019 Feb;139(2):129-134. doi: 10.1080/00016489.2018.1562217. Epub 2019 Feb 2.

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 4, 2016
• Primary Completion (ACTUAL): December 23, 2019
• Study Completion (ACTUAL): July 12, 2022

Study Registration Dates

• First Submitted: December 11, 2013
• First Submitted That Met QC Criteria: February 21, 2014
• First Posted (ESTIMATE): February 24, 2014

Study Record Updates

• Last Update Posted (ACTUAL): November 21, 2022
• Last Update Submitted That Met QC Criteria: November 16, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: Hemodialysis; Nephrology; Haemodialysis; Bone Anchored Port; Mastoid bone; Retroauricular anchored devices; Permanent central venous vascular access; Vascular Access for Haemodialysis
• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency; Renal Insufficiency, Chronic; Kidney Failure, Chronic
• Other Study ID Numbers: 12k002; CIV-13-11-011681 (REGISTRY: EUDAMED); 37790 (REGISTRY: GMDN-Code)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO