NCT03753789

Ablation Confirmation Study

A Multicenter Study to Evaluate NEUWAVE Microwave Ablation System Using Ablation Confirmation in Patients With a Soft Tissue Liver Lesion

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 46 (actual)
• Sponsor: Ethicon, Inc. · Industry
• Sex: All
• Age: 22 Years
• Healthy volunteers: Not accepted

Summary

Prospective, single-arm, multicenter study that will generate clinical data using the NEUWAVE MicroWave Ablation System with AC (Ablation Confirmation) software in patients undergoing ablation of a soft tissue liver lesion.

Detailed description

Prospective, single-arm, multicenter study that will generate clinical data on 100 adult patients using the NEUWAVE MicroWave Ablation System with AC (Ablation Confirmation) software in patients undergoing ablation of a soft tissue liver lesion. AC software is a computed tomography (CT) image processing software package available as an optional feature for use with the NEUWAVE Microwave Ablation System. AC imports images from CT scanners for display and processing during ablation procedures to assist physicians in identifying ablation targets, assessing optimal ablation probe placement, and confirming the adequacy of the ablation margin. All ablations will be performed percutaneously by an interventional radiologist while the patient is under general anesthesia or deep conscious sedation.

Conditions

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

Interventions

Type	Name	Description
DEVICE	Microwave Ablation	NEUWAVE microwave ablation of soft tissue liver lesions will be performed percutaneously by an interventional radiologist while the patient is under general anesthesia or deep conscious sedation.

Timeline

• Start date: 2019-11-05
• Primary completion: 2022-10-12
• Completion: 2022-10-12
• First posted: 2018-11-27
• Last updated: 2024-01-05
• Results posted: 2024-01-05

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated device study