Pilloxa - clinical trial
|Funding from Vinnova||SEK 198 000|
|Project duration||July 2017 - July 2018|
|Venture||Medtech4Health: Competence Enhancement in SME|
Purpose and goal
The purpose and aim of the project was to conduct a clinical trial with Pilloxa´s smart pillbox. The clinical trial has recently started and patients will soon be included once we get a go from Medical Products Agency. The purpose and aim of the project are still the same, but a delay in the project plan occurred since the technology development and testing was more complex than we previously thought. In addition to this, we also had to submit an application to the Medical Products Agency for the trial as we intend to broaden our claims on the product based on the study results.
Expected results and effects
The results and expected effects of the project are unchanged. During the course of the project, we have received clear indications from several stakeholders that health-economic data is the key for Pilloxa to be successful in the long term. Therefore, this clinical trial is the most important thing the company does. The actual results and the expected effects are realized only when the trial is completed.
Planned approach and implementation
Karolinska Trial Alliance is being used to monitor the trial, for example, KTA has given input on the study protocol, the application to the Medical Products Agency, the application for the ethical approval, the initiation of eCRF and CTA, site visit and preparation of monitor visits. Continuous project management, documentation and monitoring continues until the study is completed. Looking back, the timeline for the project should have been extended in order to complete the study. The technical challenges with the product were underestimated initially (but are now resolved).