Klinisk prövning av loopborst-assisterad finnålsaspiration av pankreascystor

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 results and effects:

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.

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.