Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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 : Terminated (Study originally suspended pending a protocol amendment but study now terminated.)
First Posted : July 27, 2018
Results First Posted : December 21, 2020
Last Update Posted : December 21, 2020
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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 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 Medically Inoperable Primary Soft Tissue Lesions of the Lung: An Initial Experience
Actual Study Start Date : June 29, 2018
Actual Primary Completion Date : December 21, 2018
Actual Study Completion Date : October 24, 2019

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. Number of Patients Whose Ablation Resulted in Technical Success [ Time Frame: Immediately post-ablation (day 0) ]
    Ablation of the target lesion according to the protocol and covered completely, with an adequate margin, as defined by the performing physician (that is, the ablation zone completely overlaps or encompasses the target lesion plus an ablative margin), as assessed by CBCT imaging, immediately following the procedure.

  2. Number of Patients Whose Ablation Resulted in Technique Efficacy [ Time Frame: 30 days post-ablation ]
    Ablation of the target lesion according to the protocol and covered completely, with an adequate margin, as defined by the performing physician (that is, the ablation zone completely overlaps or encompasses the target lesion plus an ablative margin), as assessed by CT imaging, 30 days (+/- 7 days) after the first ablation procedure.

  3. User Experience Survey (Part I) [ Time Frame: Immediately post-ablation ]
    A Sponsor-created survey completed by the treating physician immediately post-ablation. Questions were all YES/NO.

  4. User Experience Survey (Part II) [ Time Frame: Immediately post-ablation ]
    A Sponsor-created survey completed by the treating physician immediately post-ablation. This question asked the time it took to place the probe in a position that was ready for ablation.

  5. User Experience Survey (Part III) [ Time Frame: Immediately post-ablation ]
    A Sponsor-created survey completed by the treating physician immediately post-ablation. This question asked how many cone-beam CT (CBCT) scans were taken to place the probe such that it was ready for ablation.

  6. User Experience Survey (Part IV) [ Time Frame: Immediately post-ablation ]
    A Sponsor-created survey completed by the treating physician immediately post-ablation. This question asked the distance of the tip of the probe to the center of the soft-tissue lesion (in mm) just before the ablation procedure was initiated.

  7. User Experience Survey (Part V) [ Time Frame: Immediately post-ablation ]
    A Sponsor-created survey completed by the treating physician immediately post-ablation. This question asked how many times the probe had to be repositioned to complete the ablation procedure.


Secondary Outcome Measures :
  1. Number of Patients Who Experienced Target Lesion Recurrence [ Time Frame: measured at 6 months and 1 year post-ablation ]
    Analyzed at 6 months and 1 year post-ablation via CT imaging

  2. Number of Patients Who Were Readmitted to the Hospital [ Time Frame: Within 30 days post-ablation ]
    Any readmission to the hospital within 30 days of the ablation procedure.



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 ≥ 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
Layout table for location information
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
Layout table for investigator information
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
  Study Documents (Full-Text)

Documents provided by Ethicon, Inc.:
Statistical Analysis Plan  [PDF] January 29, 2020
Study Protocol  [PDF] July 25, 2018

Layout table for additonal information
Responsible Party: Ethicon, Inc.
ClinicalTrials.gov Identifier: NCT03603652    
Other Study ID Numbers: NEU_2017_06
First Posted: July 27, 2018    Key Record Dates
Results First Posted: December 21, 2020
Last Update Posted: December 21, 2020
Last Verified: December 2020

Layout table for additional information
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:
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