Safety Evaluation of Seraph® 100 to Reduce Bacteremia in Patients on Hemodialysis
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02914132|
Recruitment Status : Recruiting
First Posted : September 26, 2016
Last Update Posted : February 1, 2018
|Condition or disease||Intervention/treatment||Phase|
|Bacteremia Bacterial Infection||Device: Seraph 100 Filter||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Safety and Performance Evaluation of the Seraph® 100 Microbind® Affinity Blood Filter for Reducing Bacteremia in Patients on Hemodialysis|
|Study Start Date :||February 2016|
|Estimated Primary Completion Date :||May 2018|
|Estimated Study Completion Date :||July 2018|
Seraph 100 Filter
Renal replacement patient with bacteremia.
Device: Seraph 100 Filter
Treatment of renal replacement therapy patients with bacteremia.
Other Name: Seraph 100
- Demonstrate safety of the ExThera Medical Seraph® 100 Microbind® Affinity Blood Filter in a hemodialysis circuit assessed by rate of adverse events. [ Time Frame: 14 days ]Rate of adverse events
- Reduction of bacteria in blood passed through the Seraph 100 filter. [ Time Frame: 4 hours ]Bacteria (CFU/mL or TTP) in blood is measure during the 4 hour treatment.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02914132
|Contact: Kathleen A White, B.Sci.||firstname.lastname@example.org|
|Braunschweig, Germany, 38126|
|Contact: Stefan Buettner 069/6301-0|
|Hannöver, Germany, 30625|
|Contact: Jan Menne, Prof. 05115323000 email@example.com|
|Muenster, Germany, 48149|
|Contact: Philipp Kuempers, Prof. 0251830 philipp.Kuempers@ukmuenster.de|
|Principal Investigator:||Jan T Kielstein, MD,FASN,FERA||Klinikum Braunschweig|