BONE ANCHORED PORT for Hemodialysis Treatment

NCT02069860 | Terminated DMC

• 3 other identifiers: 12k002CIV-13-11-01168137790
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

Bone Anchored Port; Haemodialysis; Mastoid bone; Nephrology; Retroauricular anchored devices; Permanent central venous vascular access; Hemodialysis; Vascular Access for Haemodialysis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Performance - Implantation and primary healing process

  up to 18 months after Study start

Other Outcomes (3)

• Performance - removal of catheter

  up to 18 months after Study start

• Performance - Dialysis use

  up to 18 months after Study start

• Design Validation

  up to 18 months after Study start

Study Arms (1)

Access for heamodialysis treatment

EXPERIMENTAL

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)

Interventions

Bone Anchored Port System (BAP) DEVICE

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.

Also known as: Retroauricular anchored devices, Permanent central venous vascular access devices, Tunneled catheters, BAHA and Jarvik 2000 pedestal

Access for heamodialysis treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Cendres+Métaux: lead

Study Sites (1)

Inselspital Bern

Bern, 3010, Switzerland

Location

Related Publications (2)

• 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.

  PMID: 26394413 BACKGROUND

• 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.

  PMID: 30714444 RESULT

Study Officials

• Uehlinger Dominik, Prof. Dr. med.

  University Hospital, Inselspital, Berne, Switzerland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2013
• First Posted: February 24, 2014
• Study Start: April 4, 2016
• Primary Completion: December 23, 2019
• Study Completion: July 12, 2022
• Last Updated: November 21, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)