Suture-TOOL clinical evaluation

Purpose and goal:

The project aimed to carry out a clinical evaluation of Suturion´s sewing machine for fast and safe standardized abdominal closure, which forms the basis for further activities prior to apply for clinical

trial at the Medical Products Agency. The project included designing the clinical evaluation plan, writing a literature search plan and report, evaluating and analyzing collected data and writing a clinical evaluation report. These objectives have been met. Expected results and effects:

The activities in the project are necessary to design the clinical study, which in turn is a necessary step for CE marking and to reach the market and be able to start sales. Approach and implementation:

In the project, a clinical evaluation plan was first designed. This aims to assess the clinical status of the product. The plan includes a literature search plan with rationale for keywords and databases.

The literature search lands in a search report where the relevance of the articles is assessed according to predetermined criteria. The outcome shows whether there is scientific data that is relevant to the product. The literature search showed that there is no similar product on the market, which is why a clinical study is necessary for CE marking.