NCT04107766

NOLA (NeuWave Observational Liver Ablation) Registry

A Multicenter Observational Registry to Develop Ablation Parameter Guidance for Microwave Liver Ablation of Soft Tissue Lesions

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 1,254 (actual)
• Sponsor: Ethicon, Inc. · Industry
• Sex: All
• Age: 22 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter, observational registry that follows patients for a total of 5 years from the date of the first liver ablation procedure with the NEUWAVE Microwave Ablation System.

Detailed description

This is a multicenter, observational registry that follows patients for a total of 5 years from the date of the first liver ablation procedure with the NEUWAVE Microwave Ablation System. The data gathered from participating sites will be available to be analyzed to develop ablation parameter guidance for ablation approaches under varying patient liver tissue conditions and liver lesions. This is an "umbrella registry," which was included as an optional component in other NEUWAVE studies; hence, data from consenting patients who are or will be enrolled in other NEUWAVE soft tissue liver lesion ablation studies will be included in this registry. All other patients will be enrolled and followed prospectively, enrolled retrospectively with prospective, longitudinal follow up, or enrolled retrospectively with all retrospective follow up. Enrollment for this study will include up to 1,500 patients throughout the world who underwent or are scheduled to undergo microwave ablation of one or more soft tissue liver lesions using the NEUWAVE Microwave Ablation System or the NEUWAVE Microwave Ablation System with Ablation Confirmation.

Conditions

• Cancer of the Liver
• Liver Cancer
• Neoplasms, Liver

Interventions

Type	Name	Description
DEVICE	Microwave Ablation	Patients who meet the eligibility criteria will undergo microwave ablation (MWA) with the NEUWAVE Microwave Ablation System with or without Ablation Confirmation of at least one soft-tissue liver lesion, in accordance with the study site's standard-of-care (SOC) practices.

Timeline

• Start date: 2020-01-15
• Primary completion: 2025-06-18
• Completion: 2025-06-18
• First posted: 2019-09-27
• Last updated: 2026-04-17
• Results posted: 2026-04-17

Locations

28 sites across 8 countries: United States, China, France, Germany, Netherlands, Singapore, South Korea, United Kingdom

Regulatory

• FDA-regulated device study