Reduction of exposure for microbubbles of air during hemodialysis.

Reference number
Coordinator Region Västerbotten - Medicinsk och geriatrisk klinik
Funding from Vinnova SEK 525 000
Project duration August 2016 - May 2020
Status Ongoing
Venture Medtech4Health: Innovators in the healthcare sector
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.

The project description has been provided by the project members themselves and the text has not been looked at by our editors.