A major milestone in the project has been achieved, paving the way for the initiation of the PORSAV clinical investigation in Ireland.
Left: EndoTrap™ mask/sleeve system for protection of endoscopist. Centre: LeakTrap™ collector rings (black rings touching patient skin and top of trocar) Right: vacuum system.
Palliare’s devices EndoTrap and LeakTrap have received ethical approval from both the newly-formed National Office for Research Ethics Committees (NREC) for Medical Devices and Competent Authority clearance from the Health Products Regulatory Authority (HPRA).
The National Office for Research Ethics Committee for Medical Devices launched in May 2021 and the PORSAV approval is the first trial to be approved by it. NREC ensures that Ireland is an attractive place to conduct research in these important areas and maximise the opportunity for Irish patients to participate in forefront research, gaining access to innovative medicines and services.