NEUWAVE Flex Microwave Ablation System in the Ablation of Primary Soft Tissue Lesions of the Lung
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.
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This describes the study’s primary purpose.
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These are broad labels—not an eligibility decision.
Checked against the public recordLast updated Dec 21, 2020 · Source: ClinicalTrials.gov
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Interventional
Locations may change over time.
Study sponsor
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Not applicable
- Sponsor
- Ethicon, Inc.
- Interventions being studied
- Device: Microwave Ablation
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
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
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
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- City of HopeDuarte, California
- Mayo ClinicRochester, Minnesota
- New York Presbyterian-Weill Cornell MedicineNew York, New York
- FirstHealth Moore Regional HospitalPinehurst, North Carolina
- Cleveland ClinicCleveland, Ohio
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Dec 21, 2020. Always confirm current availability with the study team.