Status:
COMPLETED
Safety and Clinical Performance of a Dialyzer With a Modified Polysulfone Membrane
Lead Sponsor:
Fresenius Medical Care Deutschland GmbH
Conditions:
Renal Failure
End Stage Renal Disease
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The clinical investigation will be performed to generate clinical data on clearances and removal rates (for ß2-microglobulin, myoglobin, phosphate, creatinine, and urea) as well as biocompatibility of...
Detailed Description
The FX Coral (TD 16-1) dialyzer is a new development with a modified polysulfone membrane and is not CE marked yet. The purpose of the clinical evaluation is to generate clinical data for the CE appro...
Eligibility Criteria
Inclusion
- Minimum age of 18 years
- Informed consent signed and dated by study patient and investigator / authorized physician
- Ability to understand the nature and requirements of the study
Exclusion
- Any condition which could interfere with the patient's ability to comply with the study. This decision is at the discretion of the treating physician and relates to the general good condition of the patient (e.g. absence of any acute condition, e.g. infection or mental problem which might give reason for concern etc.).
- Ongoing participation in an interventional clinical study during the preceding 30 days
- Previous participation in this study
- Pregnancy (pregnancy test will be conducted with female patients aged less or aged 55 years) or lactation period
Key Trial Info
Start Date :
October 6 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 14 2018
Estimated Enrollment :
49 Patients enrolled
Trial Details
Trial ID
NCT03315624
Start Date
October 6 2017
End Date
March 14 2018
Last Update
March 29 2018
Active Locations (1)
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1
Georg-Haas-Dialysezentrum der PHV
Giessen, Germany, 35392