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Trial record 2 of 4 for:    NEUWAVE Microwave Ablation System

NEUWAVE Flex Microwave Ablation System in the Ablation of Primary Soft Tissue Lesions of the Lung

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: NCT03603652
Recruitment Status : Suspended (Pending protocol amendment.)
First Posted : July 27, 2018
Last Update Posted : May 14, 2019
Sponsor:
Information provided by (Responsible Party):
Ethicon, Inc.

Brief Summary:
Patients with medically inoperable primary soft tissue lesion of the lung will have transbronchial microwave ablation performed via transbronchial approach by an interventional pulmonologist or thoracic surgeon using CT imaging. 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.

Condition or disease Intervention/treatment Phase
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

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
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
Estimated Primary Completion Date : July 6, 2020
Estimated Study Completion Date : September 30, 2020

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Evaluation of the device utilizing the summary of all responses from the User Experience Survey which is an unvalidated Sponsor generated questionnaire that asks 30 individual questions about the use of the device and the procedural experience [ Time Frame: Within 23 hours of ablation procedure ]
    Device user experience will be collected from the treating physician who will complete the User Experience Survey on the same day as the ablation procedure. The questionnaire includes, but is not limited to procedure workflow and the user's assessment on ease/difficulty of using the device. The User Experience Survey will augment the Product Development Specialist's understanding of the usability of the Flexible system and determine which enhancements, if any, are needed in the future. This is not a validated questionnaire that asks 30 questions which have a yes/no answer or response from 1-5 where 1 is lowest and 5 is highest. A summary of responses to scored questions and yes/no questions will be generated across all completed questionnaires to summarize the overall user experience of the device.

  2. Percentage of patients achieving technical success defined as lack of enhancement in the ablation zone of the ablation site [ Time Frame: Within 23 hours of ablation procedure ]
    Assessment is done with review of the cone bean CT images and is defined as lack of enhancement in the ablation zone of the ablation site.

  3. Percentage of patients achieving technical efficacy defined as lack of enhancement in the ablation zone of the ablation site [ Time Frame: Within 37 days from the ablation day ]
    Assessment is done with review of the cone bean CT images and is defined as lack of enhancement in the ablation zone of the ablation site.


Secondary Outcome Measures :
  1. Incidence of Adverse events attributable to the device and procedure [ Time Frame: Day of ablation procedure through 1 year follow up ]
    Any complications attributable to the procedure, including all device-related and procedure-related adverse events and serious adverse events.

  2. Percentage of patients achieving primary efficacy meaning the percent of all treated lesions which is confirmed by CT to be successfully ablated [ Time Frame: within 23 hours of ablation procedure ]
    Determined by cone beam CT, this is the percentage of target soft tissue lesions successfully ablated after the initial ablation

  3. Percentage of patients achieving secondary efficacy meaning the percent of lesions which have been confirmed by CT to have had successful repeat ablations following the initial ablation and progression [ Time Frame: From date of first ablation through 12 months follow up period ]
    Assessed via conventional CT, this is defined as the percentage of soft tissue lesions that have undergone successful repeat ablations following identification of local soft tissue lesion progression.

  4. Lesion Recurrence rate [ Time Frame: From date of ablation through 12 month follow up ]
    Assessed via conventional CT, this is defined as the reappearance of the target lesion at the treated site

  5. Length of hospital stay [ Time Frame: From time of hospitalization post ablation procedure to time of discharge post ablation (minimum 23 hours) ]
    Length of hospital stay for the ablation procedure

  6. Hospital Readmission Rate [ Time Frame: Date of discharge from ablation procedure through 30 days post ablation procedure ]
    Defined as any readmission to the hospital


Other Outcome Measures:
  1. Patient reported quality of life measured via EORTC QLQ- C30 (Quality of Life Questionnaire Cancer 30 questions) [ Time Frame: Within 30 days prior to the ablation, on the day of the ablation, 30 days, 6 months and 12 months post ablation ]
    Quality of life (QOL) questionnaire utilizing the European Organization for Research and Treatment of Cancer (EORTC) QLQ- C (Cancer) 30. This questionnaire asks patients to rate the responses from 1-4 (1 being not at all and 4 being very much).

  2. Patient reported pain rating utilizing 0-10 pain scale [ Time Frame: Within 30 days prior to the ablation, on the day of the ablation and at 30 days post ablation. ]
    Scale rating 0-10, where 0 is no pain and 10 is maximum pain

  3. Patient reported quality of life measured via EORTC QLQ-LC13 (Quality of Life Questionnaire Lung Cancer 13 questions) [ Time Frame: Within 30 days prior to the ablation, on the day of the ablation, 30 days, 6 months and 12 months post ablation ]
    Quality of life (QOL) questionnaires utilizing the European Organization for Research and Treatment of Cancer (EORTC) QLQ-LC13 (Lung Cancer). This questionnaire asks patients to rate the responses from 1-4 (1 being not at all and 4 being very much).



Information from the National Library of Medicine

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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 ≥ 18 years old.
  3. Performance status 0-2 via ECOG (Eastern Cooperative Oncology Group) classification.
  4. Willing to fulfill all follow-up visit requirements.
  5. 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)
  6. 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)

  7. Radiographic resolution of pneumonia

Exclusion Criteria:

  1. Scheduled concurrent procedure for the target soft tissue lesion 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 coagulography at time of screening.
  5. Patient with implantable devices, including pacemakers or other electronic implants.
  6. Prior pneumonectomy or bronchiectasis.
  7. Severe neuromuscular disease.
  8. Platelet count ≤ 50,000/mm3.
  9. ASA (American Society of Anesthesiologists) score of ≥ 4.
  10. Inability to tolerate anesthesia.
  11. Expected survival less than 6 months.
  12. Clinically significant hypertension.
  13. Chronic ventilator support, which uses bi-level positive airway pressure (PAP).
  14. Endobronchial soft tissue lesions proximal to the segmental airways

Information from the National Library of Medicine

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


Locations
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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.
Investigators
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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

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Responsible Party: Ethicon, Inc.
ClinicalTrials.gov Identifier: NCT03603652    
Other Study ID Numbers: NEU_2017_06
First Posted: July 27, 2018    Key Record Dates
Last Update Posted: May 14, 2019
Last Verified: May 2019

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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.:
Lung Lesions; Soft Tissue- Lung
Additional relevant MeSH terms:
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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