· The study will begin in April 2021.
· A multi-center Randomized Controlled Trial engaging three Hospitals in Europe: Hospital Universitario La Paz (Madrid), Hospital de la Santa Creu i Sant Pau (Barcelona), Maribor University Medical Center (Slovenia).
· The Coordinating clinical investigator is Dr Carlos Asencio, from the Neurosurgery Department in Hospital Sant Pau.
· The clinical investigation is a post market study and plans to recruit 60 patients, in a total study duration of 1 year.
· The main aim of the study is to continue to gain clinical experience and show its reliability among the available standards of care systems for craniotomy closure in the market.
The Cranial LOOP family of cranial fixation devices is a smart system made of PEEK-OPTIMA™, a biocompatible polymer, for securely fixing bone flaps after craniotomies. With more than 8 years of market experience, Cranial LOOP is being used in public and private hospitals in 25 countries worldwide.