NCT03315624

Safety and Clinical Performance of a Dialyzer With a Modified Polysulfone Membrane

Safety and Clinical Performance of a Dialyzer With a Modified Polysulfone Membrane - eMPORA Study (Modified POlysulfone membRAne)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 49 (actual)
• Sponsor: Fresenius Medical Care Deutschland GmbH · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 the modified polysulfone membrane to obtain CE-certification according to the European Medical Device Directive for the FX Coral 600 (TD 16-1) dialyzer.

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 approval.

Conditions

• Renal Failure
• End Stage Renal Disease

Interventions

Type	Name	Description
DEVICE	Dialyzer	Three hemodiafiltration sessions assigned to one type of dialyzer FX Coral 600, FX 600 and FX CorDiax 600

Timeline

• Start date: 2017-10-06
• Primary completion: 2017-12-09
• Completion: 2018-03-14
• First posted: 2017-10-20
• Last updated: 2018-03-29

Locations

1 site across 1 country: Germany