Ignite Creation Date:
2025-12-25 @ 2:06 AM
Ignite Modification Date:
2026-03-01 @ 6:28 AM
Study NCT ID:
NCT02069860
Status:
TERMINATED
Last Update Posted:
2022-11-21
First Post:
2013-12-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
BONE ANCHORED PORT for Hemodialysis Treatment
Sponsor:
Cendres+Métaux
Organization:
Study Overview
Official Title:
Bone Anchored Port - a Novel Vascular Access for Hemodialysis Treatment
Status:
TERMINATED
Status Verified Date:
2022-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BAP
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.
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
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: