March 24, 2019
Global Registry Will Collect Real-World Data on Liver Lesions Treated With Ethicon's NeuWave Microwave Ablation System
March 25, 2019—Ethicon, part of Johnson & Johnson Medical Devices Companies, has launched a new global registry to collect and analyze real-world data on patients with soft tissue liver lesions ablated with the company's NeuWave microwave ablation system. Ethicon made the announcement at SIR 2019, the annual meeting of the Society of Interventional Radiology, being held March 23–28 in Austin, Texas.
The NeuWave system, which uses heat transmitted through image-guided needle-like probes to destroy soft tissue lesions, enables physicians to effectively tailor ablations for lesions of varying shapes and sizes with consistency and control.
According to the company, the multicenter, observational registry will follow approximately 1,500 patients worldwide for 5 years from the date of the patient's first liver ablation procedure with the NeuWave system. Real-world data will be collected from up to 30 centers throughout the world on the technical aspects of the procedure including ablation time under varying liver tissue and lesion conditions. Efficacy and other outcome data will also be documented and assessed at various time points over the course of the study.
The registry will also include data from consenting patients enrolled in other Ethicon-sponsored studies on microwave liver ablation with the NeuWave system in Korea and China, as well as a multicenter study that is evaluating the device using NeuWave's ablation confirmation software, which helps physicians identify ablation targets, assess appropriate probe placement, and confirm the technical success of each procedure.
Interventional radiologist, Paul Laeseke, MD, with the University of Wisconsin School of Medicine and Public Health in Madison, Wisconsin, consulted on the design of the registry. In the company's announcement, Dr. Laeseke commented, "The goal of the registry is to systematically and comprehensively develop ablation parameter guidance for the microwave ablation of liver lesions with the NeuWave system. Microwave ablation is an important treatment option that is increasingly being utilized throughout the world, and this data may provide new insights into factors that are critical for successful outcomes across a range of patients, clinical settings and health care providers. The registry will be an important contribution to our understanding of microwave ablation and support its further adoption."