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

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

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.

Study Overview

• Status: Terminated
• Conditions: Non-Small Cell Lung Cancer; Lung Cancer; Neoplasms, Lung; Carcinoma, Non-Small Cell Lung; Non-Small-Cell Lung Carcinoma; Cancer of Lung; Cancer of the Lung
• Intervention / Treatment: Device: Microwave Ablation

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.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Duarte, California, United States, 91010
      • City of Hope
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic
  • New York
    • New York, New York, United States, 10065
      • New York Presbyterian-Weill Cornell Medicine
  • North Carolina
    • Pinehurst, North Carolina, United States, 28374
      • Firsthealth Moore Regional Hospital
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Microwave Ablation; Ablations will be performed under general anesthesia via transbronchial approach by an interventional pulmonologist or thoracic surgeon.	Device: Microwave Ablation; Ablations will be performed under general anesthesia via transbronchial approach by an interventional pulmonologist or thoracic surgeon. Prior to the ablation, the treating physician will perform an endobronchial ultrasound to confirm disease staging.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Patients Whose Ablation Resulted in Technical Success	Ablation of the target lesion according to the protocol and covered completely, with an adequate margin, as defined by the performing physician (that is, the ablation zone completely overlaps or encompasses the target lesion plus an ablative margin), as assessed by CBCT imaging, immediately following the procedure.	Immediately post-ablation (day 0)
Number of Patients Whose Ablation Resulted in Technique Efficacy	Ablation of the target lesion according to the protocol and covered completely, with an adequate margin, as defined by the performing physician (that is, the ablation zone completely overlaps or encompasses the target lesion plus an ablative margin), as assessed by CT imaging, 30 days (+/- 7 days) after the first ablation procedure.	30 days post-ablation
User Experience Survey (Part I)	A Sponsor-created survey completed by the treating physician immediately post-ablation. Questions were all YES/NO.	Immediately post-ablation
User Experience Survey (Part II)	A Sponsor-created survey completed by the treating physician immediately post-ablation. This question asked the time it took to place the probe in a position that was ready for ablation.	Immediately post-ablation
User Experience Survey (Part III)	A Sponsor-created survey completed by the treating physician immediately post-ablation. This question asked how many cone-beam CT (CBCT) scans were taken to place the probe such that it was ready for ablation.	Immediately post-ablation
User Experience Survey (Part IV)	A Sponsor-created survey completed by the treating physician immediately post-ablation. This question asked the distance of the tip of the probe to the center of the soft-tissue lesion (in mm) just before the ablation procedure was initiated.	Immediately post-ablation
User Experience Survey (Part V)	A Sponsor-created survey completed by the treating physician immediately post-ablation. This question asked how many times the probe had to be repositioned to complete the ablation procedure.	Immediately post-ablation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Patients Who Experienced Target Lesion Recurrence	Analyzed at 6 months and 1 year post-ablation via CT imaging	measured at 6 months and 1 year post-ablation
Number of Patients Who Were Readmitted to the Hospital	Any readmission to the hospital within 30 days of the ablation procedure.	Within 30 days post-ablation

Collaborators and Investigators

• Sponsor: Ethicon, Inc.
• Investigators: Principal Investigator: Thomas Gildea, MD, The Cleveland Clinic; Principal Investigator: Michael Pritchett, MD, Firsthealth Moore Regional Hospital; Principal Investigator: Bradley Pua, MD, Cornell

Study record dates

Study Major Dates

• Study Start (Actual): June 29, 2018
• Primary Completion (Actual): December 21, 2018
• Study Completion (Actual): October 24, 2019

Study Registration Dates

• First Submitted: May 16, 2018
• First Submitted That Met QC Criteria: July 26, 2018
• First Posted (Actual): July 27, 2018

Study Record Updates

• Last Update Posted (Actual): December 21, 2020
• Last Update Submitted That Met QC Criteria: December 18, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: Lung Lesions; Soft Tissue- Lung
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms by Histologic Type; Neoplasms; Lung Diseases; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Carcinoma
• Other Study ID Numbers: NEU_2017_06

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No