NEUWAVE Flex Microwave Ablation System in the Ablation of Primary Soft Tissue Lesions of the Lung

Ethicon, Inc.10 enrolled

Overview

Patients with medically inoperable primary soft tissue lesion of the lung will have transbronchial microwave ablation performed via transbronchial approach by an interventional pulmonologist or thoracic surgeon using CT imaging. Prior to the ablation procedure, the treating physician will use endobronchial ultrasound to confirm staging. Patients will be followed for one year following the ablation procedure for efficacy and safety.

Patients with medically inoperable primary soft tissue lesion of the lung (lesions less than or equal to 2cm and located in the outer two-thirds of the lung and not closer than 1cm to the pleura) will have transbronchial microwave ablation performed using CT imaging. All ablations will be performed under general anesthesia via transbronchial approach by an interventional pulmonologist or thoracic surgeon. Prior to the ablation procedure, the treating physician will use endobronchial ultrasound to confirm staging. Patients will be followed for one year following the ablation procedure for efficacy and safety with specific follow-up visits at 30 days, 6 months, and 12 months post-ablation. A user experience questionnaire is completed by the treating physician to better understand the ease of the procedure.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Cancer of Lung Cancer of the Lung

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Signed informed consent. 2. Patients ≥ 18 years old. 3. Performance status 0-2 via ECOG (Eastern Cooperative Oncology Group) classification. 4. Willing to fulfill all follow-up visit requirements. 5. Medically inoperable primary soft tissue lesion of the lung or patient election not to have surgery. (Medically inoperable is defined per the following indicators: post op predictive FEV1 (forced expiratory volume in 1 second) \< 40%; DLCO (diffusing capacity of the lung for carbon monoxide) \< 40%; hypoxemia or hypercapnia diabetes with end-organ damage; or severe cerebral, cardiovascular, peripheral vascular disease, or chronic heart disease) 6. One soft tissue lesion ≤ 2 cm in the outer two thirds of the lung and not closer than 1 cm to the pleura. (Outer two thirds of the lung is defined as peripheral beyond the segmental airway, past the segmental bronchi, such that proximal endobronchial soft tissue lesions are avoided; soft tissue lesions should not be contiguous with the pleura) 7. Radiographic resolution of pneumonia Exclusion Criteria: 1. Scheduled concurrent procedure for the target soft tissue lesion 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 coagulography at time of screening. 5. Patient with implantable devices, including pacemakers or other electronic implants. 6. Prior pneumonectomy or bronchiectasis. 7. Severe neuromuscular disease. 8. Platelet count ≤ 50,000/mm3. 9. ASA (American Society of Anesthesiologists) score of ≥ 4. 10. Inability to tolerate anesthesia. 11. Expected survival less than 6 months. 12. Clinically significant hypertension. 13. Chronic ventilator support, which uses bi-level positive airway pressure (PAP). 14. Endobronchial soft tissue lesions proximal to the segmental airways

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

Cleveland Clinic

Cleveland, Ohio, United States

Outcomes

Primary Outcomes

Number of Patients Whose Ablation Resulted in Technical Success

Ablation of the target lesion according to the protocol and covered completely, with an adequate margin, as defined by the performing physician (that is, the ablation zone completely overlaps or encompasses the target lesion plus an ablative margin), as assessed by CBCT imaging, immediately following the procedure.

Time frame: Immediately post-ablation (day 0)

Number of Patients Whose Ablation Resulted in Technique Efficacy

Time frame: 30 days post-ablation

User Experience Survey (Part I)

A Sponsor-created survey completed by the treating physician immediately post-ablation. Questions were all YES/NO.