Clinical trial NCT03603652: NEUWAVE Flex Microwave Ablation System in the Ablation of Primary Soft Tissue Lesions of the Lung
Official title: A Multicenter Study of the NEUWAVE Flex Microwave Ablation System in the Ablation of Medically Inoperable Primary Soft Tissue Lesions of the Lung: An Initial Experience
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: 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
Keywords: Lung Lesions; Soft Tissue- Lung
Lead sponsor: Ethicon, Inc.
Sponsor class: INDUSTRY
First posted: 2018-07-27
Enrollment: 10
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 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Patients Whose Ablation Resulted in Technical Success
timeFrame: Immediately post-ablation (day 0)
measure: Number of Patients Whose Ablation Resulted in Technique Efficacy
timeFrame: 30 days post-ablation
measure: User Experience Survey (Part I)
timeFrame: Immediately post-ablation
measure: User Experience Survey (Part II)
timeFrame: Immediately post-ablation
measure: User Experience Survey (Part III)
timeFrame: Immediately post-ablation
measure: User Experience Survey (Part IV)
timeFrame: Immediately post-ablation
measure: User Experience Survey (Part V)
timeFrame: Immediately post-ablation
Secondary outcomes:
measure: Number of Patients Who Experienced Target Lesion Recurrence
timeFrame: measured at 6 months and 1 year post-ablation
measure: Number of Patients Who Were Readmitted to the Hospital
timeFrame: Within 30 days post-ablation
Other outcomes:
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:
affiliation: The Cleveland Clinic
name: Thomas Gildea, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: FirstHealth Moore Regional Hospital
name: Michael Pritchett, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Mayo Clinic
name: Janani Reisenauer, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Cornell
name: Bradley Pua, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: City of Hope Medical Center
name: Jae Kim, MD
role: PRINCIPAL_INVESTIGATOR
References: