Cortrium is moving the clinical trial testings of the C3 device on cancer patients to Germany. The Ethical Committee (Lübeck) and The Federal Institute for Drugs and Medical Devices (BfArM) have approved the start-up of trials at the University Medical Centre in Schleswig-Holstein.

After approval by the Danish Medicines Agency in 2016 of the testing of the C3 device on cancer patients, I thought a repetition of the trial in Germany was straight forward with the approval from the German authorities. I was wrong. Several obstacles came in my way before Cortrium obtained the approval.

Here is our path: 

1. Multicentre testing: First we went for expanding the Danish trial at Zealand University Hospital in Naestved. But the Ethical Committee demanded that not even a comma in the Danish protocol could be changed. As the feedback from the healthcare personnel in Naestved had resulted in significant improvements to the Cortrium app, we had no reasons to repeat the test of an already outdated and archaic app.

2. The Full Monty: Instead, we saddled the horse for a complete wrap-up of the existing protocol. Nurses and medical doctors were included in the dialogue together with professors from the nurse college and Zealand University Hospital. Suddenly too many stakeholders took the ownership of the trials. I started out being flattered by the omnipotent interests. However, many calls and meetings later we all counted up our resources and decided to go for similar test set-up in Kiel and Lübeck with the C3 device and the improved Cortrium app.

3. Only German, please: The next challenge was the German authorities. Even though the clinical testing of medical equipment is governed by European directives (Medical Device Directive (93/42/EEC) & Good Clinical Practice Directive (2005/28/EC)), the national legislation makes different procedures. In Germany the “Medizinproduktegesetz (MPG)” rules. And all communication is in German with German authorities. It is possible to explain yourself in English writing. But you get the answer in German.

4. Two approval procedures: Unlike the Danish Act for medical device testing, BfArM allows the manufacturer to decide between two procedures for applying for conducting a clinical trial, respectively 1) The light version with limited documentation (10 working days approval time), and 2) The version with full documentation as if the equipment had the CE-marking already (60 working days approval time). How do you find out whether you must apply within the light or full version? You call BfArM and talk your case. We were lucky. We got the light version. In Denmark, there is only one procedure that documentation wise falls in between the two German procedures.

5. Data security: One thing you can’t skip is documentation regarding data security. Germans are obsessed with protecting patient data. And in contrast to the Danish Medicines Agency, both BfArM, the Ethical Committees and the hospitals were very concerned about the patient data storage embedded on the C3 device, and the Bluetooth transfer of data to the Cortrium app. We had to secure proper data encryption and – again and again – explaining the securing of the patient data.

And finally, we made it. The protocol and the documentation were approved by BfArM and the Ethical Committee (Lübeck) at the cancer departments in Lübeck and Kiel. The Lübeck trial testing is planned to start 3. May’17. In Kiel, the start is set for late June’17 including the approval from the Ethical Committee (Kiel).

More about the Trials

The clinical trial testing of the C3 device is including: 1) Data validation: Data validation of pulse and respiratory rate measurements. 2) Infection: An exploratory study regarding an alternative measurement of the patients’ infection levels by analyzing all the C3 sensor data. A total of up to 65 patients are included in the trials in Naestved, Kiel and Lübeck.

 

The Clinical trial testing at the University Medical Centre in Schleswig-Holstein is supported by: