Post-market observation register in Germany

EASEE®-PEARL

Providing Early Assessment in Real Life subjects with focal medically refractory seizures

A study to obtain long-term effectiveness data of the EASEE® system in a real-world setting.

Duration of clinical investigation: 3 years

Course of study:

Inclusion: The implantation is planned up to six months after inclusion OR has been performed within twelve months prior to inclusion.
Implantation: Treatment-related procedure according to standard care.
Follow-up visits as part of routine care (at least once a year).
End of study takes place approx. 36 months after implantation.

Patient profile & key inclusion criteria:

Patient is at least 18 years old.
There is a clinical diagnosis of pharmacoresistant focal epilepsy.
Treatment failure of two adequately selected seizure suppressants in sufficient dosage.
Study participants must comply with the application guidelines of the EASEE® system.
An implantation of the EASEE® system is planned in the next 6 months or was implanted in the last 12 months before inclusion in the study.

Scientific research lead EASEE®-PEARL

Prof. Dr. Bettina Schmitz

Clinic for Neurology - Stroke Unit - Center for Epilepsy, Vivantes Humboldt-Clinic Berlin

In collaboration with Prof. H. Hammer and Dr. T. Mayer.

Study Office
+49 (30) 130 122218
pearl@vivantes.de

Contact

Do you have further questions about the study design and how you can recruit your patients as study participants?

Please feel free to contact us!

Send an email to info@precisis.de

Study for adolescents aged 12 and over

EASEE4YOU

The EASEE4YOU study evaluates transcranial focal cortex stimulation for medically refractory epilepsies in adolescents. Read more about the study design. Do your patients fit the patient profile?

Learn more about EASEE4YOU