NCT03713099

NEUWAVE Flexible Probe Study #2

A Multicenter Study of the NEUWAVE Flex Microwave Ablation System in the Ablation of Secondary Soft Tissue Lesions of the Lung

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Ethicon, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Patients with medically inoperable and operable secondary soft tissue lesion(s) of the lung will have transbronchial microwave ablation performed using cone beam CT for probe guidance and confirmation.

Detailed description

Adult patients with medically inoperable and operable secondary soft tissue lesion(s) of the lung less than 2cm will undergo transbronchial microwave ablation performed by an interventional pulmonologist or thoracic surgeon using cone beam CT imaging for probe guidance and confirmation on ablation outcome. All treated patients will be followed for one year following the ablation procedure for efficacy and safety.

Conditions

• Cancer of the Lung
• Lung Cancer
• Neoplasms, Lung
• Carcinoma, Non-Small Cell Lung
• Non-Small Cell Lung Cancer
• Non-Small Cell Lung Carcinoma

Interventions

Type	Name	Description
DEVICE	Microwave ablation	Microwave ablations will be performed under general anesthesia via a transbronchial approach by an interventional pulmonologist or thoracic surgeon. Prior to the ablation, the treating physician will perform an endobronchial ultrasound (EBUS) to confirm disease staging.

Timeline

• Start date: 2020-07-31
• Primary completion: 2022-03-31
• Completion: 2022-03-31
• First posted: 2018-10-19
• Last updated: 2020-06-02

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated device study