Lung Cancer Clinical Trial
Official title:
A Multicenter Study of the NEUWAVE Flex Microwave Ablation System in the Ablation of Secondary Soft Tissue Lesions of the Lung
Verified date | May 2020 |
Source | Ethicon, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | March 31, 2022 |
Est. primary completion date | March 31, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
United States | Cleveland Clinic | Cleveland | Ohio |
United States | City of Hope | Duarte | California |
United States | New York Presbyterian-Weill Cornell Medicine | New York | New York |
United States | FirstHealth Moore Regional Hospital | Pinehurst | North Carolina |
United States | Mayo Clinic | Rochester | Minnesota |
Lead Sponsor | Collaborator |
---|---|
Ethicon, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | EORTC QLQ-C30 | 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. | 1 year post-ablation | |
Other | EORTC QLQ-LC13 | 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. | 1 year post-ablation | |
Other | Numeric Pain Scale | 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. | 30 days post-ablation | |
Primary | Device User Experience Survey | 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. | Day of ablation (day 0) | |
Primary | Technical Success (lesion completely ablated) | 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. | Day of ablation (day 0) | |
Primary | Technique Efficacy (lesion completely ablated) | 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). | 30 days post-ablation | |
Secondary | Adverse Events | 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). | 1 year post-ablation | |
Secondary | Primary Efficacy Rate | 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. | Day of ablation (day 0) | |
Secondary | Secondary Efficacy Rate | 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). | 1 year post-ablation | |
Secondary | Target Lesion Recurrence | 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). | 1 year post-ablation | |
Secondary | Length of Hospital Stay | 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). | Day of ablation (day 0) | |
Secondary | Hospital Readmission Rate | The Hospital Readmission Rate is defined as the percentage of patients who were readmitted to the hospital within 30 days of the ablation procedure. | 30 days post-ablation |
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