Learn More About Seraph 100 in Use
Initiated at Uniformed Services University of the Health Sciences (USUHS), the program is an off-shoot of the DARPA dialysis-like therapy (DLT) program aimed at developing and/or evaluating adjunctive therapies in a pandemic setting when no proven therapies are available. Seraph 100 is being tested in the ongoing PURIFY Program.
For additional details about the study, visit: https://deployedmedicine.com/market/215/content/1676
US IDE Multicenter Prospective Randomized Controlled Trial: PURIFY-RCT
Multi-center, randomized controlled trial to evaluate the initial safety and efficacy of a novel extracorporeal blood purification (EBP) therapy in critically ill patients with pathogen associated shock. Patients will be randomized to receive either Arm 1: Seraph 100 treatment plus ‘State of the Art’ or Arm 2: ‘State of the Art’ care alone. “State of the Art care” will be defined as the treatment algorithms outlined in the Surviving Sepsis Campaign for the treatment of septic shock.
For additional details about the study, visit: https://www.clinicaltrials.gov/ct2/show/NCT05011656
Multi-center, observational 3-arm cohort study composed of subjects with informed consent (1) treated with Seraph 100 after the date of the EUA approval (retrospective), (2) additional eligible admitted patients also meeting inclusion/exclusion criteria (prospective), and (3) Historical matched control group composed of admitted patients at participating sites with severe COVID-19 infection, meeting EUA treatment criteria, but not treated with Seraph 100 (matched control).
For additional details about the study, visit: https://clinicaltrials.gov/ct2/show/NCT04606498
European COVID-19 Registry
Registry of COVID-19 patients treated with the Seraph 100 Microbind Affinity Blood Filter (COSA) with the purpose to investigate the effectiveness and safety of the Seraph 100 in the treatment of COVID-19 patients.
For additional details about the study, visit: https://clinicaltrials.gov/ct2/show/NCT04361500
European Post Market Study
Safety and performance evaluation of Seraph 100 in the reduction of pathogen load from the blood in septic patients with suspected, life-threatening bloodstream infection. 21 clinical sites in 8 countries are participating in this study including major teaching hospitals and medical centers in Austria, Belgium, France, Germany, Italy, the Netherlands, Poland, and the United Kingdom.
For additional details about the study, visit: https://clinicaltrials.gov/ct2/show/NCT04260789
Seraph 100 CE Mark Clinical Trial (completed)
ExThera Medical completed a multi-center, non-randomized European trial for Seraph 100 in 2019. The study enrolled patients at four centers in Germany.
For additional details about the study, visit: https://clinicaltrials.gov/show/NCT02914132