Clinical trial NCT03713099: NEUWAVE Flexible Probe Study #2
Official title: A Multicenter Study of the NEUWAVE Flex Microwave Ablation System in the Ablation of Secondary Soft Tissue Lesions of the Lung
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Cancer of the Lung
Lung Cancer
Neoplasms, Lung
Carcinoma, Non-Small Cell Lung
Non-Small Cell Lung Cancer
Non-Small Cell Lung Carcinoma
Keywords: Microwave Ablation
Lead sponsor: Ethicon, Inc.
Sponsor class: INDUSTRY
First posted: 2018-10-19
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Device User Experience Survey
timeFrame: Day of ablation (day 0)
measure: Technical Success (lesion completely ablated)
timeFrame: Day of ablation (day 0)
measure: Technique Efficacy (lesion completely ablated)
timeFrame: 30 days post-ablation
Secondary outcomes:
measure: Adverse Events
timeFrame: 1 year post-ablation
measure: Primary Efficacy Rate
timeFrame: Day of ablation (day 0)
measure: Secondary Efficacy Rate
timeFrame: 1 year post-ablation
measure: Target Lesion Recurrence
timeFrame: 1 year post-ablation
measure: Length of Hospital Stay
timeFrame: Day of ablation (day 0)
measure: Hospital Readmission Rate
timeFrame: 30 days post-ablation
Other outcomes:
measure: EORTC QLQ-C30
timeFrame: 1 year post-ablation
measure: EORTC QLQ-LC13
timeFrame: 1 year post-ablation
measure: Numeric Pain Scale
timeFrame: 30 days post-ablation
Locations:
city: Duarte
country: United States
facility: City of Hope
state: California
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: New York
country: United States
facility: New York Presbyterian-Weill Cornell Medicine
state: New York
city: Pinehurst
country: United States
facility: FirstHealth Moore Regional Hospital
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
Study officials:
References: