22 October 2018 | News
The trial, titled ‘ENCASE’, is a single-arm, open-label study, evaluating safety and performance of LIQOSEAL® in reducing CSF leakage following elective cranial surgery
Polyganics, a medical technology company developing, manufacturing and commercializing bioresorbable medical devices, today announced that it has initiated enrollment of patients into a first-in-human clinical trial of LIQOSEAL®, its dura sealant patch. The self-adhesive patch has been developed to reduce cerebrospinal fluid (CSF) leakage following brain surgery.
The trial, titled ‘ENCASE’, is a single-arm, open-label study, evaluating safety and performance of LIQOSEAL® in reducing CSF leakage following elective cranial surgery. Up to 40 adult patients will be recruited at three sites across the Netherlands and Switzerland, with follow-up spanning a 90-day period.
CSF leakage is a common complication of neurosurgical procedures and can lead to life-threatening infections such as meningitis. LIQOSEAL®, developed using Polyganics’ bioresorbable polymers, is designed as an adjunct to closure of the outer protective membrane (‘dura’) surrounding the brain after brain surgery, thereby minimizing leakage of cerebrospinal fluid (CSF).
The patch has been engineered to encourage regeneration of the dura and to degrade naturally and safely within the body over time, once the membrane has healed.