NEUWAVE Flexible Probe Study #2
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ClinicalTrials.gov Identifier: NCT03713099 |
Recruitment Status :
Withdrawn
(Changed study design prior to any patients enrolled.)
First Posted : October 19, 2018
Last Update Posted : June 2, 2020
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Condition or disease | Intervention/treatment | Phase |
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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 |
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 |

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
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 greater or equal to 18 years of age
- Performance status 0-2 (Eastern Cooperative Oncology Group classification [ECOG])
- Willing to fulfill all follow-up visit requirements
- Medically inoperable and operable secondary soft tissue lesion(s) of the lung
- 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:
- Scheduled concurrent procedure for the target soft tissue lesion(s) other than those that are lung-related
- Pregnant or breastfeeding
- Physical or psychological condition that would impair study participation
- Patients with uncorrectable coagulopathy at the time of screening
- Patient with implantable devices, including pacemakers or other electronic implants
- Prior pneumonectomy or bronchiectasis
- Severe neuromuscular disease
- Patient count less than or equal to 50,000/mm cubed
- ASA (American Society of Anesthesiologists) score of greater than or equal to 4
- Inability to tolerate anesthesia
- Expected survival less than 6 months
- Clinically significant hypertension
- 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)
- Endobronchial soft tissue lesions proximal to the segmental airways
- Imaging findings of active pulmonary infection
- The patient was judged unsuitable for study participation by the Investigator for any other reason.

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): NCT03713099
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 |
Responsible Party: | Ethicon, Inc. |
ClinicalTrials.gov Identifier: | NCT03713099 |
Other Study ID Numbers: |
NEU_2018_01 |
First Posted: | October 19, 2018 Key Record Dates |
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 |
Microwave Ablation |
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 |