Back to resultsNEUWAVE Flexible Probe Study #2
Primary Purpose
Cancer of the Lung, Lung Cancer, Neoplasms, Lung
Status
Withdrawn
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 the Lung focused on measuring Microwave Ablation
Eligibility Criteria
Inclusion Criteria:
- Signed Informed Consent
- Patients greater or equal to 18 years of age
- Performance status 0-2 (Eastern Cooperative Oncology Group classification [ECOG])
- Willing to fulfill all follow-up visit requirements
- Medically inoperable and operable secondary soft tissue lesion(s) of the lung
- 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:
- Scheduled concurrent procedure for the target soft tissue lesion(s) other than those that are lung-related
- Pregnant or breastfeeding
- Physical or psychological condition that would impair study participation
- Patients with uncorrectable coagulopathy at the time of screening
- Patient with implantable devices, including pacemakers or other electronic implants
- Prior pneumonectomy or bronchiectasis
- Severe neuromuscular disease
- Patient count less than or equal to 50,000/mm cubed
- ASA (American Society of Anesthesiologists) score of greater than or equal to 4
- Inability to tolerate anesthesia
- Expected survival less than 6 months
- Clinically significant hypertension
- 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)
- Endobronchial soft tissue lesions proximal to the segmental airways
- Imaging findings of active pulmonary infection
- The patient was judged unsuitable for study participation by the Investigator for any other reason.
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
Microwave ablations will be performed under general anesthesia via a transbronchial approach performed by an interventional pulmonologist or thoracic surgeon.
Outcomes
Primary Outcome Measures
Device User Experience Survey
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)
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)
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
Adverse Events
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
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
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
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
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
The Hospital Readmission Rate is defined as the percentage of patients who were readmitted to the hospital within 30 days of the ablation procedure.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03713099
Brief Title
NEUWAVE Flexible Probe Study #2
Official Title
A Multicenter Study of the NEUWAVE Flex Microwave Ablation System in the Ablation of Secondary Soft Tissue Lesions of the Lung
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Withdrawn
Why Stopped
Changed study design prior to any patients enrolled.
Study Start Date
July 31, 2020 (Anticipated)
Primary Completion Date
March 31, 2022 (Anticipated)
Study Completion Date
March 31, 2022 (Anticipated)
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
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer of the Lung, Lung Cancer, Neoplasms, Lung, Carcinoma, Non-Small Cell Lung, Non-Small Cell Lung Cancer, Non-Small Cell Lung Carcinoma
Keywords
Microwave Ablation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Microwave Ablation
Arm Type
Experimental
Arm Description
Microwave ablations will be performed under general anesthesia via a transbronchial approach performed by an interventional pulmonologist or thoracic surgeon.
Intervention Type
Device
Intervention Name(s)
Microwave ablation
Intervention Description
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 Measure Information:
Title
Device User Experience Survey
Description
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.
Time Frame
Day of ablation (day 0)
Title
Technical Success (lesion completely ablated)
Description
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.
Time Frame
Day of ablation (day 0)
Title
Technique Efficacy (lesion completely ablated)
Description
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).
Time Frame
30 days post-ablation
Secondary Outcome Measure Information:
Title
Adverse Events
Description
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).
Time Frame
1 year post-ablation
Title
Primary Efficacy Rate
Description
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.
Time Frame
Day of ablation (day 0)
Title
Secondary Efficacy Rate
Description
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).
Time Frame
1 year post-ablation
Title
Target Lesion Recurrence
Description
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).
Time Frame
1 year post-ablation
Title
Length of Hospital Stay
Description
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).
Time Frame
Day of ablation (day 0)
Title
Hospital Readmission Rate
Description
The Hospital Readmission Rate is defined as the percentage of patients who were readmitted to the hospital within 30 days of the ablation procedure.
Time Frame
30 days post-ablation
Other Pre-specified Outcome Measures:
Title
EORTC QLQ-C30
Description
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.
Time Frame
1 year post-ablation
Title
EORTC QLQ-LC13
Description
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.
Time Frame
1 year post-ablation
Title
Numeric Pain Scale
Description
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.
Time Frame
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 greater or equal to 18 years of age
Performance status 0-2 (Eastern Cooperative Oncology Group classification [ECOG])
Willing to fulfill all follow-up visit requirements
Medically inoperable and operable secondary soft tissue lesion(s) of the lung
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:
Scheduled concurrent procedure for the target soft tissue lesion(s) other than those that are lung-related
Pregnant or breastfeeding
Physical or psychological condition that would impair study participation
Patients with uncorrectable coagulopathy at the time of screening
Patient with implantable devices, including pacemakers or other electronic implants
Prior pneumonectomy or bronchiectasis
Severe neuromuscular disease
Patient count less than or equal to 50,000/mm cubed
ASA (American Society of Anesthesiologists) score of greater than or equal to 4
Inability to tolerate anesthesia
Expected survival less than 6 months
Clinically significant hypertension
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)
Endobronchial soft tissue lesions proximal to the segmental airways
Imaging findings of active pulmonary infection
The patient was judged unsuitable for study participation by the Investigator for any other reason.
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
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NEUWAVE Flexible Probe Study #2
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