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NEUWAVE Flexible Probe Study #2

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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Recruitment Status : Withdrawn (Changed study design prior to any patients enrolled.)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
Sponsor:
Information provided by (Responsible Party):
Ethicon, Inc.

Tracking Information
First Submitted Date  ICMJE October 18, 2018
First Posted Date  ICMJE October 19, 2018
Last Update Posted Date June 2, 2020
Estimated Study Start Date  ICMJE July 31, 2020
Estimated Primary Completion Date March 31, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 18, 2018)
  • 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).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 18, 2018)
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: October 18, 2018)
  • 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.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE NEUWAVE Flexible Probe Study #2
Official Title  ICMJE A Multicenter Study of the NEUWAVE Flex Microwave Ablation System in the Ablation of Secondary Soft Tissue Lesions of the Lung
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Cancer of the Lung
  • Lung Cancer
  • Neoplasms, Lung
  • Carcinoma, Non-Small Cell Lung
  • Non-Small Cell Lung Cancer
  • Non-Small Cell Lung Carcinoma
Intervention  ICMJE 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.
Study Arms  ICMJE Experimental: Microwave Ablation
Microwave ablations will be performed under general anesthesia via a transbronchial approach performed by an interventional pulmonologist or thoracic surgeon.
Intervention: Device: Microwave ablation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: May 29, 2020)
0
Original Estimated Enrollment  ICMJE
 (submitted: October 18, 2018)
40
Estimated Study Completion Date  ICMJE March 31, 2022
Estimated Primary Completion Date March 31, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03713099
Other Study ID Numbers  ICMJE NEU_2018_01
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ethicon, Inc.
Study Sponsor  ICMJE Ethicon, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Ethicon, Inc.
Verification Date May 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP