Back to resultsNEUWAVE Flex Microwave Ablation System in the Ablation of Primary Soft Tissue Lesions of the Lung
Primary Purpose
Cancer of Lung, Cancer of the Lung, Lung Cancer
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Microwave Ablation
Sponsored by
About this trial
This is an interventional treatment trial for Cancer of Lung focused on measuring Lung Lesions; Soft Tissue- Lung
Eligibility Criteria
Inclusion Criteria:
- Signed informed consent.
- Patients ≥ 18 years old.
- Performance status 0-2 via ECOG (Eastern Cooperative Oncology Group) classification.
- Willing to fulfill all follow-up visit requirements.
- 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)
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)
- Radiographic resolution of pneumonia
Exclusion Criteria:
- Scheduled concurrent procedure for the target soft tissue lesion other than those that are lung related.
- Pregnant or breastfeeding.
- Physical or psychological condition that would impair study participation.
- Patients with uncorrectable coagulography at time of screening.
- Patient with implantable devices, including pacemakers or other electronic implants.
- Prior pneumonectomy or bronchiectasis.
- Severe neuromuscular disease.
- Platelet count ≤ 50,000/mm3.
- ASA (American Society of Anesthesiologists) score of ≥ 4.
- Inability to tolerate anesthesia.
- Expected survival less than 6 months.
- Clinically significant hypertension.
- Chronic ventilator support, which uses bi-level positive airway pressure (PAP).
- Endobronchial soft tissue lesions proximal to the segmental airways
Sites / Locations
- City of Hope
- Mayo Clinic
- New York Presbyterian-Weill Cornell Medicine
- FirstHealth Moore Regional Hospital
- Cleveland Clinic
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Microwave Ablation
Arm Description
Ablations will be performed under general anesthesia via transbronchial approach by an interventional pulmonologist or thoracic surgeon.
Outcomes
Primary Outcome Measures
Number of Patients Whose Ablation Resulted in Technical Success
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.
Number of Patients Whose Ablation Resulted in Technique Efficacy
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.
User Experience Survey (Part I)
A Sponsor-created survey completed by the treating physician immediately post-ablation. Questions were all YES/NO.
User Experience Survey (Part II)
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.
User Experience Survey (Part III)
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.
User Experience Survey (Part IV)
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.
User Experience Survey (Part V)
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
Number of Patients Who Experienced Target Lesion Recurrence
Analyzed at 6 months and 1 year post-ablation via CT imaging
Number of Patients Who Were Readmitted to the Hospital
Any readmission to the hospital within 30 days of the ablation procedure.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03603652
Brief Title
NEUWAVE Flex Microwave Ablation System in the Ablation of Primary Soft Tissue Lesions of the Lung
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Terminated
Why Stopped
Study originally suspended pending a protocol amendment but study now terminated.
Study Start Date
June 29, 2018 (Actual)
Primary Completion Date
December 21, 2018 (Actual)
Study Completion Date
October 24, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ethicon, Inc.
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
Keywords
Lung Lesions; Soft Tissue- Lung
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Microwave Ablation
Arm Type
Experimental
Arm Description
Ablations will be performed under general anesthesia via transbronchial approach by an interventional pulmonologist or thoracic surgeon.
Intervention Type
Device
Intervention Name(s)
Microwave Ablation
Intervention Description
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 Measure Information:
Title
Number of Patients Whose Ablation Resulted in Technical Success
Description
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.
Time Frame
Immediately post-ablation (day 0)
Title
Number of Patients Whose Ablation Resulted in Technique Efficacy
Description
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.
Time Frame
30 days post-ablation
Title
User Experience Survey (Part I)
Description
A Sponsor-created survey completed by the treating physician immediately post-ablation. Questions were all YES/NO.
Time Frame
Immediately post-ablation
Title
User Experience Survey (Part II)
Description
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.
Time Frame
Immediately post-ablation
Title
User Experience Survey (Part III)
Description
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.
Time Frame
Immediately post-ablation
Title
User Experience Survey (Part IV)
Description
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.
Time Frame
Immediately post-ablation
Title
User Experience Survey (Part V)
Description
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.
Time Frame
Immediately post-ablation
Secondary Outcome Measure Information:
Title
Number of Patients Who Experienced Target Lesion Recurrence
Description
Analyzed at 6 months and 1 year post-ablation via CT imaging
Time Frame
measured at 6 months and 1 year post-ablation
Title
Number of Patients Who Were Readmitted to the Hospital
Description
Any readmission to the hospital within 30 days of the ablation procedure.
Time Frame
Within 30 days post-ablation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Signed informed consent.
Patients ≥ 18 years old.
Performance status 0-2 via ECOG (Eastern Cooperative Oncology Group) classification.
Willing to fulfill all follow-up visit requirements.
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)
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)
Radiographic resolution of pneumonia
Exclusion Criteria:
Scheduled concurrent procedure for the target soft tissue lesion other than those that are lung related.
Pregnant or breastfeeding.
Physical or psychological condition that would impair study participation.
Patients with uncorrectable coagulography at time of screening.
Patient with implantable devices, including pacemakers or other electronic implants.
Prior pneumonectomy or bronchiectasis.
Severe neuromuscular disease.
Platelet count ≤ 50,000/mm3.
ASA (American Society of Anesthesiologists) score of ≥ 4.
Inability to tolerate anesthesia.
Expected survival less than 6 months.
Clinically significant hypertension.
Chronic ventilator support, which uses bi-level positive airway pressure (PAP).
Endobronchial soft tissue lesions proximal to the segmental airways
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Gildea, MD
Organizational Affiliation
The Cleveland Clinic
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Michael Pritchett, MD
Organizational Affiliation
FirstHealth Moore Regional Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Janani Reisenauer, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Bradley Pua, MD
Organizational Affiliation
Cornell
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jae Kim, MD
Organizational Affiliation
City of Hope Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
City of Hope
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
New York Presbyterian-Weill Cornell Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
FirstHealth Moore Regional Hospital
City
Pinehurst
State/Province
North Carolina
ZIP/Postal Code
28374
Country
United States
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
12. IPD Sharing Statement
Learn more about this trial
NEUWAVE Flex Microwave Ablation System in the Ablation of Primary Soft Tissue Lesions of the Lung
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