Ethicon, a part of Johnson & Johnson Medical Devices, has launched a new global registry to collect data on liver lesions ablated with its NEUWAVE Microwave Ablation System.
Image: Ethicon's NEUWAVE Microwave Ablation System. Photo: Courtesy of PRNewsfoto/Ethicon, Inc.
Ethicon made the announcement at the Society of Interventional Radiology (SIR 2019), which is being held in Austin, Texas.
The multicenter, observational registry will follow about 1,500 patients across the world for five years from the date of their first liver ablation procedure with NEUWAVE System, said Ethicon.
NEUWAVE System is a minimally invasive microwave ablation technology where heat transmitted through image-guided needle-like probes will destroy soft tissue lesions.
The real-world data will be collected from up to 30 centers across the world and will include technical aspects of procedure such as ablation time under varying liver tissue and lesion conditions.
During the course of the study, efficacy and other outcome data will also be collected and assessed at several time intervals.
Furthermore, the company’s newly launched registry will collect data from consenting patients registered in other Ethicon-sponsored studies on microwave liver ablation with the NEUWAVE System in Korea and China and another multicenter study which is evaluating the device using NEUWAVE’s Ablation Confirmation Software.
The software helps physicians in identifying ablation targets, assesses placement of the probes and confirms procedure’s success.
Ethicon global head medical & clinical franchise lead Piet Hinoul said: “Microwave is the fastest growing ablation modality and as this treatment grows, Ethicon is committed to working with clinicians throughout the world to generate robust clinical evidence for the innovative NEUWAVE Microwave Ablation System. This will help inform treatment decisions and improvements in procedural efficiency and patient outcomes.”
The NEUWAVE Microwave Ablation System has been cleared for use in ablation (coagulation) of soft tissue in percutaneous, open surgical and in conjunction with laparoscopic surgical settings, including partial or complete ablation of non-resectable liver tumors. However, the system has not been cleared for treating any specific disease or condition and it has not been indicated for used in cardiac procedures.