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

• ClinicalTrials.gov Identifier: NCT03603652
• Recruitment Status: Terminated
• First Posted: July 27, 2018
• Results First Posted: December 21, 2020
• Last Update Posted: December 21, 2020
• Sponsor: Ethicon, Inc.
• Information provided by (Responsible Party): Ethicon, Inc.

Study Description

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.

Condition or disease	Intervention/treatment	Phase
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	Device: Microwave Ablation	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 10 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: June 29, 2018
• Actual Primary Completion Date: December 21, 2018
• Actual Study Completion Date: October 24, 2019

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. Number of Patients Whose Ablation Resulted in Technical Success [ Time Frame: Immediately post-ablation (day 0) ]
   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.
2. Number of Patients Whose Ablation Resulted in Technique Efficacy [ Time Frame: 30 days post-ablation ]
   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.
3. User Experience Survey (Part I) [ Time Frame: Immediately post-ablation ]
   A Sponsor-created survey completed by the treating physician immediately post-ablation. Questions were all YES/NO.
4. User Experience Survey (Part II) [ Time Frame: Immediately post-ablation ]
   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.
5. User Experience Survey (Part III) [ Time Frame: Immediately post-ablation ]
   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.
6. User Experience Survey (Part IV) [ Time Frame: Immediately post-ablation ]
   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.
7. User Experience Survey (Part V) [ Time Frame: Immediately post-ablation ]
   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.

Secondary Outcome Measures :

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

Eligibility Criteria

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

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

Contacts and Locations

Locations

United States, California

City of Hope

Duarte, California, United States, 91010

United States, Minnesota

Mayo Clinic

Rochester, Minnesota, United States, 55905

United States, New York

New York Presbyterian-Weill Cornell Medicine

New York, New York, United States, 10065

United States, North Carolina

FirstHealth Moore Regional Hospital

Pinehurst, North Carolina, United States, 28374

United States, Ohio

Cleveland Clinic

Cleveland, Ohio, United States, 44195

Sponsors and Collaborators

Ethicon, Inc.

Investigators

• Principal Investigator: Thomas Gildea, MD; The Cleveland Clinic
• Principal Investigator: Michael Pritchett, MD; FirstHealth Moore Regional Hospital
• Principal Investigator: Janani Reisenauer, MD; Mayo Clinic
• Principal Investigator: Bradley Pua, MD; Cornell
• Principal Investigator: Jae Kim, MD; City of Hope Medical Center

  Study Documents (Full-Text)

Documents provided by Ethicon, Inc.:

Statistical Analysis Plan  [PDF] January 29, 2020

Study Protocol  [PDF] July 25, 2018

More Information

• Responsible Party: Ethicon, Inc.
• ClinicalTrials.gov Identifier: NCT03603652
• Other Study ID Numbers: NEU_2017_06
• First Posted: July 27, 2018
• Results First Posted: December 21, 2020
• Last Update Posted: December 21, 2020
• Last Verified: December 2020

• 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

Keywords provided by Ethicon, Inc.:

Lung Lesions; Soft Tissue- Lung

Additional relevant MeSH terms:

Carcinoma; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms