NEUWAVE Flexible Probe Study #2

Ethicon

Status: Withdrawn

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

Treatments: Device: Microwave ablation

Study type: Interventional

Funder types: Industry

Identifiers

NCT03713099

NEU_2018_01

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Microwave Ablation

Experimental group

Description:

Microwave ablations will be performed under general anesthesia via a transbronchial approach performed by an interventional pulmonologist or thoracic surgeon.

Treatment:

Device: Microwave ablation