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

Stopped early · Not applicable

Conditions studied: Cancer of Lung, Cancer of the Lung, Lung Cancer, Neoplasms, Lung, Carcinoma, Non-Small Cell Lung, Non-Small Cell Lung Cancer, Non-Small-Cell Lung Carcinoma

In brief

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.

Key facts

Study ID

NCT03603652

Run by

Ethicon, Inc.

People needed

10

Starts

2018-06-29

Expected to finish

2019-10-24

Last updated by the study team

2020-12-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Signed informed consent.
• Patients ≥ 18 years old.
• Performance status 0-2 via ECOG (Eastern Cooperative Oncology Group) classification.
• Willing to fulfill all follow-up visit requirements.
• 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)
• 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)
• Radiographic resolution of pneumonia

You may not qualify if…

• Scheduled concurrent procedure for the target soft tissue lesion other than those that are lung related.
• Pregnant or breastfeeding.
• Physical or psychological condition that would impair study participation.
• Patients with uncorrectable coagulography at time of screening.
• Patient with implantable devices, including pacemakers or other electronic implants.
• Prior pneumonectomy or bronchiectasis.
• Severe neuromuscular disease.
• Platelet count ≤ 50,000/mm3.
• ASA (American Society of Anesthesiologists) score of ≥ 4.
• Inability to tolerate anesthesia.
• Expected survival less than 6 months.
• Clinically significant hypertension.
• Chronic ventilator support, which uses bi-level positive airway pressure (PAP).
• Endobronchial soft tissue lesions proximal to the segmental airways

Where it is running

• 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

Full record on ClinicalTrials.gov

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