NEUWAVE Flexible Probe Study #2

• ClinicalTrials.gov Identifier: NCT03713099
• Recruitment Status: Withdrawn
• First Posted: October 19, 2018
• Last Update Posted: June 2, 2020
• Sponsor: Ethicon, Inc.
• Information provided by (Responsible Party): Ethicon, Inc.

Study Description

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.

Condition or disease	Intervention/treatment	Phase
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:

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 0 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 Secondary Soft Tissue Lesions of the Lung
• Estimated Study Start Date: July 31, 2020
• Estimated Primary Completion Date: March 31, 2022
• Estimated Study Completion Date: March 31, 2022

Arms and Interventions

Arm	Intervention/treatment
Experimental: Microwave Ablation; Microwave ablations will be performed under general anesthesia via a transbronchial approach performed by an interventional pulmonologist or thoracic surgeon.	Device: Microwave ablation; Microwave ablations will be performed under general anesthesia via a transbronchial approach by an interventional pulmonologist or thoracic surgeon. Prior to the ablation, the treating physician will perform an endobronchial ultrasound (EBUS) to confirm disease staging.

Outcome Measures

Primary Outcome Measures :

1. Device User Experience Survey [ Time Frame: Day of ablation (day 0) ]
   The Device User Experience Survey is an unvalidated, Sponsor-generated questionnaire aimed to increase the Sponsor's understanding of the usability of the NEUWAVE microwave ablation system. The questionnaire asks approximately 30 questions (includes yes/no responses, rating scales, and fill-in-the-blank sections) and is to be completed by the treating physician at the completion of each ablation. A summary of all treating physician responses will be generated at the completion of the study to summarize the overall user experience with the device.
2. Technical Success (lesion completely ablated) [ Time Frame: Day of ablation (day 0) ]
   Technical Success is determined by the treating physician and is defined as the ablation zone completely overlapping or encompassing the target lesion plus an ablative margin, as assessed by cone beam CT imaging, immediately following the ablation procedure.
3. Technique Efficacy (lesion completely ablated) [ Time Frame: 30 days post-ablation ]
   Technique Efficacy is determined by the treating physician and is defined as the ablation zone completely overlapping or encompassing the target lesion plus an ablative margin, as assessed by cone beam CT imaging, at Visit 3 (i.e. 30 days post-ablation).

Secondary Outcome Measures :

1. Adverse Events [ Time Frame: 1 year post-ablation ]
   Any AEs attributable to the ablation procedure, including all device-related, procedure-related, and SAEs, evaluated from the start of the ablation procedure throughout the entirety of the study (i.e. through 1 year post-ablation).
2. Primary Efficacy Rate [ Time Frame: Day of ablation (day 0) ]
   The Primary Efficacy Rate is the percentage of target lesions successfully eradicated following the first ablation procedure, as assessed using CT imaging by the treating physician on the day of ablation.
3. Secondary Efficacy Rate [ Time Frame: 1 year post-ablation ]
   The Secondary Efficacy Rate is defined as the percentage of soft tissue lesions that have undergone successful repeat ablations following identification of local soft tissue lesions progression, as assessed using CT imaging by the treating physician throughout the entirety of the study (i.e. 1 year post-ablation).
4. Target Lesion Recurrence [ Time Frame: 1 year post-ablation ]
   Target Lesion Recurrence is defined as the reappearance of the lesion(s) at the treated site, as assessed using CT imaging by the treating physician throughout the entirety of the study (i.e. through 1 year post-ablation).
5. Length of Hospital Stay [ Time Frame: Day of ablation (day 0) ]
   The Length of Hospital Stay is defined as the length of time of hospitalization from the end of the ablation procedure to the time of discharge (up to 23 hours post-ablation).
6. Hospital Readmission Rate [ Time Frame: 30 days post-ablation ]
   The Hospital Readmission Rate is defined as the percentage of patients who were readmitted to the hospital within 30 days of the ablation procedure.

Other Outcome Measures:

1. EORTC QLQ-C30 [ Time Frame: 1 year post-ablation ]
   The EORTC (European Organization for Research and Treatment of Cancer) QLQ-C30 is a quality of life questionnaire with 30 questions aimed specifically for cancer patients. Patients will complete this questionnaire at each study visit.
2. EORTC QLQ-LC13 [ Time Frame: 1 year post-ablation ]
   The EORTC (European Organization for Research and Treatment of Cancer) QLQ-C30 is a quality of life questionnaire with 13 questions aimed specifically for lung cancer patients. The questionnaire asks patients to rate their responses on a scale from 1-4 (1 being "not at all" and 4 being "very much"). Patients will complete this questionnaire at each study visit.
3. Numeric Pain Scale [ Time Frame: 30 days post-ablation ]
   The Numeric Pain Scale is a questionnaire where the patient reports their pain on a scale from 0-10 (where 0 is 'no pain' and 10 is 'maximum pain). Patients will complete this questionnaire at each study visit through 30 days post-ablation.

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 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.

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.

More Information

• Responsible Party: Ethicon, Inc.
• ClinicalTrials.gov Identifier: NCT03713099
• Other Study ID Numbers: NEU_2018_01
• First Posted: October 19, 2018
• Last Update Posted: June 2, 2020
• Last Verified: May 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.:

Microwave Ablation

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