NEUWAVE Flex Microwave Ablation System in the Ablation of Primary Soft Tissue Lesions of the Lung
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ClinicalTrials.gov Identifier: NCT03603652 |
Recruitment Status :
Terminated
(Study originally suspended pending a protocol amendment but study now terminated.)
First Posted : July 27, 2018
Results First Posted : December 21, 2020
Last Update Posted : December 21, 2020
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Condition or disease | Intervention/treatment | Phase |
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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 |
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 (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 |

Arm | Intervention/treatment |
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Experimental: Microwave Ablation
Ablations will be performed under general anesthesia via transbronchial approach by an interventional pulmonologist or thoracic surgeon.
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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. |
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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
- 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.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Signed informed consent.
- Patients ≥ 18 years old.
- Performance status 0-2 via ECOG (Eastern Cooperative Oncology Group) classification.
- Willing to fulfill all follow-up visit requirements.
- 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)
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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)
- Radiographic resolution of pneumonia
Exclusion Criteria:
- Scheduled concurrent procedure for the target soft tissue lesion other than those that are lung related.
- Pregnant or breastfeeding.
- Physical or psychological condition that would impair study participation.
- Patients with uncorrectable coagulography at time of screening.
- Patient with implantable devices, including pacemakers or other electronic implants.
- Prior pneumonectomy or bronchiectasis.
- Severe neuromuscular disease.
- Platelet count ≤ 50,000/mm3.
- ASA (American Society of Anesthesiologists) score of ≥ 4.
- Inability to tolerate anesthesia.
- Expected survival less than 6 months.
- Clinically significant hypertension.
- Chronic ventilator support, which uses bi-level positive airway pressure (PAP).
- Endobronchial soft tissue lesions proximal to the segmental airways

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03603652
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 |
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 |
Documents provided by Ethicon, Inc.:
Responsible Party: | Ethicon, Inc. |
ClinicalTrials.gov Identifier: | NCT03603652 |
Other Study ID Numbers: |
NEU_2017_06 |
First Posted: | July 27, 2018 Key Record Dates |
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 |
Lung Lesions; Soft Tissue- Lung |
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 |