Johnson & Johnson (NYSE:JNJ) subsidiary Ethicon said it has launched a 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.
The multicenter, observational registry will follow approximately 1,500 patients worldwide for five years from the date of their first liver ablation procedure with the Neuwave system, a minimally invasive microwave ablation technology that uses heat transmitted through image-guided needle-like probes to destroy soft tissue lesions.
The company will collect data 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, according to the company, which announced the registry at the Society of Interventional Radiology (SIR 2019) meeting in Austin, Texas.
Neuwave is a minimally invasive system designed to enable physicians to tailor ablations for lesions of varying shapes and sizes with consistency and control, according to Ethicon. Most patients leave the hospital the same day with only a bandage at the probe insertion site, according to a 2014 study published in the Journal of Vascular Interventional Radiology.
“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,” said University of Wisconsin School of Medicine and Public Health interventional radiologist Dr. Paul Laeseke in a prepared statement.
“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,” added Laeske, who consulted on the registry’s design. “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 and a multicenter study that is evaluating the device using Neuwave’s ablation confirmation software, which is designed to help 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,” said Piet Hinoul, global head and leader of Ethicon’s medical and clinical franchise. “This will help inform treatment decisions and improvements in procedural efficiency and patient outcomes.”
Neuwave is cleared for the ablation of soft tissue in percutaneous, open surgical and in conjunction with laparoscopic surgical settings, including the partial or complete ablation of non-resectable liver tumors. It is not cleared for the treatment of any specific disease or condition and is not indicated for use in cardiac procedures.