iVascular has announced the initiation of Opal, the first-in-human study with the new embolic liquid Amber, based on a radiopaque biocompatible copolymer. Opal is a prospective, single-arm, multicentre study with a sample size of 70 patients requiring peripheral embolization. The study is a collaboration between 10 centres in Spain that specialise in embolization and will be led by Fernando Gómez (Hospital La Fe, Valencia, Spain).
The main objective of the Opal study is to evaluate the safety and efficacy of Amber in vascular anomalies, haemorrhages, aneurysms, pseudoaneurysms, type II endoleaks, varicose veins, portal veins, hypervascular tumours, and pathological organs.
The results of the study will provide crucial data on the safety and efficacy of Amber, as determined by the rate of complete vascular occlusion in all the evaluated indications. Patients will be followed up at discharge and at one, three and six months after intervention. Throughout the study, Gómez, together with the clinical events committee (CEC) and the data safety monitoring board (DSMB), will ensure patient safety and the scientific integrity of the data obtained.
“The Opal study may be the first step towards changing the way embolization with liquid is performed. All of us who have been able to test Amber agree that beyond its excellent properties in terms of penetration and visualisation, it will increase safety in this type of treatment,’ says Gómez.
The iVascular research and development team assures that Amber has been designed to overcome the limitations of current embolic liquids, a recent press release states. “Achieving total control of the product together with a homogeneous and intrinsic visualisation, being a ready to use liquid, have been the main objectives of Amber’s design,” says Sofía Valle, project leader for the development of the embolic.
