E!115208, CEDAR, Multi4

Purpose and goal:

The purpose and objectives of the project have been achieved through the development and adaptation of the Multi4 instrument for a cystoscope intended for diagnosis and treatment of bladder cancer. Preclinical tests have been conducted to verify the safety and functionality of the instrument. The regulatory documentation has been compiled, and we have finally received approval from the Medical Products Agency to initiate a clinical study, which has now also commenced.

Expected results and effects:

The use of the Multi4 instrument for bladder cancer allows patients to be diagnosed and treated in the same session, eliminating the need to schedule a separate surgery. Patients do not require general anesthesia but can undergo treatment with local anesthesia. The procedure is efficient as only one instrument is used for multiple functions, avoiding the need to switch instruments. Patients can go home immediately after the procedure and do not need to stay in the hospital.

Approach and implementation:

The project has held regular meetings with the involved parties. The Multi4 instrument has been developed and customized to fit a cystoscope. It has then been evaluated for safety and functionality on pigs. Necessary tests for sterilization and biocompatibility have been conducted, and the regulatory documentation has been compiled for submission to the Medical Products Agency for approval to conduct a clinical study.