A new global registry from Ethicon (part of Johnson & Johnson medical device companies) has been launched to collect and analyse real-world data on patients with soft tissue liver lesions ablated with the company’s Neuwave microwave ablation system. Ethicon announced this registry at the Society of Interventional Radiology (SIR) annual meeting (23–28 March, Austin, USA).
The multicentre, observational registry will follow approximately 1,500 patients worldwide for a total of five years from the date of their first liver ablation procedure with the Neuwave system.
Real-world data will be collected from up to 30 centres 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 goal of the registry is to systematically and comprehensively develop ablation parameter guidance for the microwave ablation of liver lesions with the Neuwave system,” says Paul Laeseke, an interventional radiologist at the University of Wisconsin School of Medicine and Public Health (Madison, USA), who consulted on the design of the registry. “Microwave ablation is an important treatment option that is increasingly being utilised 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.”
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 multicentre study that is evaluating the device using Neuwave’s ablation confirmation software, which, according to a press release, helps physicians identify ablation targets, assess appropriate probe placement and confirm the technical success of each procedure.
“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,” comments Piet Hinoul, global head medical and clinical franchise lead for Ethicon.
The Neuwave system, which Ethicon claim is the microwave ablation market leader in the USA, is a minimally invasive system that enables physicians to effectively tailor ablations for lesions of varying shapes and sizes with consistency and control. A press release states that studies have shown microwave ablation has strong efficacy and a favourable complication profile, with most patients leaving the hospital the same day with a bandage at the probe insertion site.