NEUWAVE Flexible Probe Study #2

Ethicon, Inc.

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

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

Microwave ablationDEVICE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Signed Informed Consent 2. Patients greater or equal to 18 years of age 3. Performance status 0-2 (Eastern Cooperative Oncology Group classification \[ECOG\]) 4. Willing to fulfill all follow-up visit requirements 5. Medically inoperable and operable secondary soft tissue lesion(s) of the lung 6. A maximum of two ipsilateral soft tissue lesions less than or equal to 2cm in the outer two-thirds of the lung and not closer than 1cm to the pleura. Lesion size must be measured with at least 2-dimensional imaging. Exclusion Criteria: 1. Scheduled concurrent procedure for the target soft tissue lesion(s) other than those that are lung-related 2. Pregnant or breastfeeding 3. Physical or psychological condition that would impair study participation 4. Patients with uncorrectable coagulopathy at the time of screening 5. Patient with implantable devices, including pacemakers or other electronic implants 6. Prior pneumonectomy or bronchiectasis 7. Severe neuromuscular disease 8. Patient count less than or equal to 50,000/mm cubed 9. ASA (American Society of Anesthesiologists) score of greater than or equal to 4 10. Inability to tolerate anesthesia 11. Expected survival less than 6 months 12. Clinically significant hypertension 13. Chronic, continuous ventilator support, which uses bi-level positive airway pressure (PAP) to improve lung function for severe conditions (however, intermittent PAP, for non-pulmonary conditions, such as sleep apnea, is permitted) 14. Endobronchial soft tissue lesions proximal to the segmental airways 15. Imaging findings of active pulmonary infection 16. The patient was judged unsuitable for study participation by the Investigator for any other reason.

Locations (5)

City of Hope

Duarte, California, United States

Mayo Clinic

Rochester, Minnesota, United States

New York Presbyterian-Weill Cornell Medicine

New York, New York, United States

FirstHealth Moore Regional Hospital

Pinehurst, North Carolina, United States

Outcomes

Primary Outcomes

Device User Experience Survey

The Device User Experience Survey is an unvalidated, Sponsor-generated questionnaire aimed to increase the Sponsor's understanding of the usability of the NEUWAVE microwave ablation system. The questionnaire asks approximately 30 questions (includes yes/no responses, rating scales, and fill-in-the-blank sections) and is to be completed by the treating physician at the completion of each ablation. A summary of all treating physician responses will be generated at the completion of the study to summarize the overall user experience with the device.

Time frame: Day of ablation (day 0)

Technical Success (lesion completely ablated)

Technical Success is determined by the treating physician and is defined as the ablation zone completely overlapping or encompassing the target lesion plus an ablative margin, as assessed by cone beam CT imaging, immediately following the ablation procedure.

Time frame: Day of ablation (day 0)

Technique Efficacy (lesion completely ablated)

Technique Efficacy is determined by the treating physician and is defined as the ablation zone completely overlapping or encompassing the target lesion plus an ablative margin, as assessed by cone beam CT imaging, at Visit 3 (i.e. 30 days post-ablation).

Time frame: 30 days post-ablation

Secondary Outcomes

Adverse Events

Any AEs attributable to the ablation procedure, including all device-related, procedure-related, and SAEs, evaluated from the start of the ablation procedure throughout the entirety of the study (i.e. through 1 year post-ablation).

Time frame: 1 year post-ablation

Primary Efficacy Rate

The Primary Efficacy Rate is the percentage of target lesions successfully eradicated following the first ablation procedure, as assessed using CT imaging by the treating physician on the day of ablation.

Data from ClinicalTrials.gov

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