End-Stage Renal Disease Requiring HaemodialysisBAPNCT02069860
BONE ANCHORED PORT for Hemodialysis Treatment
A study testing Bone Anchored Port System (BAP) in people with End-Stage Renal Disease Requiring Haemodialysis and Hemodialysis Access Failure (Disorder), run by Cendres+Métaux at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End-Stage Renal Disease Requiring Haemodialysis, Hemodialysis Access Failure (Disorder)
- What is being tested?
- Bone Anchored Port System (BAP)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteSwitzerland
- Study dates
- 4 Apr 2016to 12 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 21Show fewer
- 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.
- 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.
- Multiple participation of one subject in this clinical investigation.
- Inability to understand German and to give written informed consent.
- Patients suffering from epilepsy, addiction or other condition resulting in a higher risk of falling.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- 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
- 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
- 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%
- 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
- 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
- Being tested
- Bone Anchored Port System (BAP)
- Keywords
- Bone Anchored Port, Haemodialysis, Mastoid bone, Nephrology, Retroauricular anchored devices, Permanent central venous vascular access, Hemodialysis, Vascular Access for Haemodialysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bone Anchored Port System (BAP)Device
Also called Retroauricular anchored devices, Permanent central venous vascular access devices, Tunneled catheters, BAHA and Jarvik 2000 pedestal
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: Bone Anchored Port System (BAP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: up to 12 months after Study start
Secondary outcomes (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
Measured: up to 18 months after Study start
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2014 (estimated)
- Study start4 Apr 2016
- Primary completion23 Dec 2019
- Study completion12 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for End-Stage Renal Disease Requiring HaemodialysisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cendres+Métaux
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Uehlinger Dominik, Prof. Dr. med., Principal investigator, University Hospital, Inselspital, Berne, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02069860
- Sponsor's protocol ID
- 12k002
- Other IDs
- CIV-13-11-011681, 37790
- Acronym
- BAP
- Status last verified
- Nov 2022
- First submitted
- 11 Dec 2013
- Last updated
- 21 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
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.
PubMed 26394413Caversaccio 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.
PubMed 30714444
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bone Anchored Port - a Novel Vascular Access for Hemodialysis Treatment
- ClinicalTrials.gov ID
- NCT02069860
- Acronym / sponsor ID
- BAP / 12k002
- Keywords
- Bone Anchored Port, Haemodialysis, Mastoid bone, Nephrology, Retroauricular anchored devices, Permanent central venous vascular access, Hemodialysis, Vascular Access for Haemodialysis
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Cendres+MétauxIndustry (pharma, biotech, devices)
- Study start
- 4 Apr 2016 (actual)
- Primary completion
- 23 Dec 2019 (actual)
- Study completion
- 12 Jul 2022 (actual)
- First posted
- 24 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- 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
- 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
- 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%
- 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
- 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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Access for heamodialysis treatment | Experimental | Device: Bone Anchored Port System (BAP)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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (21 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bone Anchored Port System (BAP)Also: Retroauricular anchored devices, Permanent central venous vascular access devices, Tunneled catheters, BAHA and Jarvik 2000 pedestalThe 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. | Device | Access for heamodialysis treatment |
Primary outcome
Device survival probability after one year
Time frame: up to 12 months after Study start
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).
1 secondary outcome
Performance - Implantation and primary healing process
Time frame: up to 18 months after Study start
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2022.
- Background: PubMed 26394413Stieger 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.
- Results publication: PubMed 30714444Caversaccio 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Uehlinger Dominik, Prof. Dr. med. principal investigator
University Hospital, Inselspital, Berne, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bone Anchored Port System (BAP) in people with End-Stage Renal Disease Requiring Haemodialysis and Hemodialysis Access Failure (Disorder), run by Cendres+Métaux at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 21 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Device survival probability after one year (time frame: up to 12 months after Study start). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02069860, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2022.