Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03713099
Recruitment Status : Not yet recruiting
First Posted : October 19, 2018
Last Update Posted : July 25, 2019
Sponsor:
Information provided by (Responsible Party):
Ethicon, Inc.

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.

Condition or disease Intervention/treatment Phase
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:
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.

Layout table for study information
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 Secondary Soft Tissue Lesions of the Lung
Estimated Study Start Date : January 1, 2020
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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).


Secondary Outcome Measures :
  1. 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).

  2. 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.

  3. 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).

  4. 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).

  5. 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).

  6. 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.


Other Outcome Measures:
  1. 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.

  2. 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.

  3. 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.



Information from the National Library of Medicine

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.


Layout table for eligibility information
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 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.

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): NCT03713099


Contacts
Layout table for location contacts
Contact: Bertha Fearon 908-524-3749 bfearon1@its.jnj.com
Contact: Erin Meyers 908-218-2296 eprifog1@its.jnj.com

Locations
Layout table for location information
United States, California
City of Hope Not yet recruiting
Duarte, California, United States, 91010
Contact: Jae Kim         
Principal Investigator: Jae Kim         
United States, Minnesota
Mayo Clinic Not yet recruiting
Rochester, Minnesota, United States, 55905
Contact: Janani Reisenauer         
Principal Investigator: Janani Reisenauer         
United States, New York
New York Presbyterian-Weill Cornell Medicine Not yet recruiting
New York, New York, United States, 10065
Contact: Bradley Pua         
Principal Investigator: Bradley Pua         
United States, North Carolina
FirstHealth Moore Regional Hospital Not yet recruiting
Pinehurst, North Carolina, United States, 28374
Contact: Michael Prithcett         
Principal Investigator: Michael Pritchett         
United States, Ohio
Cleveland Clinic Not yet recruiting
Cleveland, Ohio, United States, 44195
Contact: Thomas Gildea         
Principal Investigator: Thomas Gildea         
Sponsors and Collaborators
Ethicon, Inc.

Layout table for additonal information
Responsible Party: Ethicon, Inc.
ClinicalTrials.gov Identifier: NCT03713099     History of Changes
Other Study ID Numbers: NEU_2018_01
First Posted: October 19, 2018    Key Record Dates
Last Update Posted: July 25, 2019
Last Verified: July 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Ethicon, Inc.:
Microwave Ablation

Additional relevant MeSH terms:
Layout table for MeSH terms
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