Klinisk prövning av loopborst-assisterad finnålsaspiration av pankreascystor
| Reference number | |
| Coordinator | Kungliga Tekniska Högskolan - KTH Skolan för elektroteknik och datavetenskap |
| Funding from Vinnova | SEK 2 398 360 |
| Project duration | April 2023 - April 2025 |
| Status | Ongoing |
| Venture | Swelife and Medtech4Health - Collaborative Projects for Improved Health |
| Call | Swelife and Medtech4Health - Collaborative projects for better health autumn 2022 |
Purpose and goal
The purpose and objective of the project is to prove safety and effectiveness in a clinical study of a new innovative medical device to better diagnose pancreatic cancer and which is manufactured by a Swedish company in Sweden with the capacity to scale towards a world market.
Expected effects and result
We expect to have designed a product that can be manufactured in a cost-effective manner and that fulfills regulatory demands in accordance with the EU Medical Device Directive. We also expect to be able to demonstrate safe use of the product and effective collection of cellular material from human pancreatic cysts. With such results, we will be able to move forward towards a CE marking and further international commercialization.
Planned approach and implementation
We plan to develop a prototype during the spring/summer to establish the technical file. We will then produce a zero series of 50 devices and at the same time perform risk and quality assesments required for an in-house developed medical device within Region Västerbotten. With the product, we will conduct a clinical trial with 12+12 patients in Region Västerbotten.