Reduction of exposure for microbubbles of air during hemodialysis.
|Coordinator||Region Västerbotten - Medicinsk och geriatrisk klinik|
|Funding from Vinnova||SEK 525 000|
|Project duration||August 2016 - May 2020|
|Call||Medtech4Health: Innovators in the healthcare sector 2016|
Purpose and goal
The aim of the project is to - clarify the benefit of Emboless (EMB) in reducing microbubbles of air (MbA) compared to other systems in clinical practice -achieve increased experience of the production of EMB through cooperating companies - achieve knowledge of efficacy and userfriendlyness from the clinical study -spread knowledge of the efficacy of EMB among the medical profession and companies in the field.
Expected results and effects
Preliminary results show that EMB beneficially reduces MbA from the dialysis system even compared to present systems. A good contact with producers is expected to facilitate the production including environmental aspects. The clinical studies will enlighten our knowledge about effectivity aspects thereby improving patient safety and user friendliness. The results will enable us to spread knowledge of EMB efficacy among the medical profession and companies in the field.
Planned approach and implementation
EMB will be produced (test series and in vitro tested) JOct 2016. Those results will be the basis for an application to the Swedish Medical Product Agency to perform a clinical study (Nov 2016). Preliminary results (Phase 1) will help to clarify the number of patients needed for adequate power for the clinical trial (case-control with patient as the own control) comparing EMB and a system already used in market (May 2017). Based on those results international dialysis companies will be invited for cooperation (Dec 2017) and results reported internationally.