Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:06 AM
Ignite Modification Date:
2025-12-25 @ 2:06 AM
NCT ID:
NCT02069860
Eligibility Criteria:
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02069860
Study Brief:
Protocol Section:
NCT02069860