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Study originally suspended pending a protocol amendment but study now terminated.
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Microwave Ablation | Experimental | Ablations will be performed under general anesthesia via transbronchial approach by an interventional pulmonologist or thoracic surgeon. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Microwave Ablation | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Immediately post-ablation (day 0) |
| 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. | 30 days post-ablation |
| User Experience Survey (Part I) | A Sponsor-created survey completed by the treating physician immediately post-ablation. Questions were all YES/NO. | Immediately post-ablation |
| 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. | Immediately post-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. | Immediately post-ablation |
| User Experience Survey (Part IV) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients Who Experienced Target Lesion Recurrence | Analyzed at 6 months and 1 year post-ablation via CT imaging | measured at 6 months and 1 year post-ablation |
| Number of Patients Who Were Readmitted to the Hospital |
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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:
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| Name | Affiliation | Role |
|---|---|---|
| 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 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope | Duarte | California | 91010 | United States | ||
| Mayo Clinic |
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| ID | Title | Description |
|---|---|---|
| FG000 | Microwave Ablation | Each participant underwent microwave ablation to the original soft tissue lesion in the lung at single visit. The treating physician determined the ablation time and power used on a case-by-case basis. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 29, 2020 | Sep 22, 2020 |
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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. |
| Immediately post-ablation |
| 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. | Immediately post-ablation |
Any readmission to the hospital within 30 days of the ablation procedure.
| Within 30 days post-ablation |
| Rochester |
| Minnesota |
| 55905 |
| United States |
| New York Presbyterian-Weill Cornell Medicine | New York | New York | 10065 | United States |
| FirstHealth Moore Regional Hospital | Pinehurst | North Carolina | 28374 | United States |
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| COMPLETED |
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| NOT COMPLETED |
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10 patients were enrolled and treated
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| ID | Title | Description |
|---|---|---|
| BG000 | Microwave Ablation | Each participant underwent microwave ablation to the original soft tissue lesion in the lung at single visit. The treating physician determined the ablation time and power used on a case-by-case basis. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age of patient at the time they signed the Informed Consent Form. | Mean | Standard Deviation | Years |
| |||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| |||||||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| |||||||||||||||||||||||
| BMI | Body Mass Index (BMI) | Mean | Standard Deviation | kg/m^2 |
| |||||||||||||||||||||
| Smoking Status | Patients who were current smokers, former smokers, or non-smokers. | Count of Participants | Participants |
| ||||||||||||||||||||||
| Radiation History | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | All treated patients. | Posted | Count of Participants | Participants | Immediately post-ablation (day 0) |
|
|
| ||||||||||||||||||||||||||
| Primary | 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. | Patients analyzed at 30 days post-ablation. | Posted | Count of Participants | Participants | 30 days post-ablation |
|
| |||||||||||||||||||||||||||
| Secondary | Number of Patients Who Experienced Target Lesion Recurrence | Analyzed at 6 months and 1 year post-ablation via CT imaging | Only 9 patients were analyzed at 6 months post-ablation as 1 patient passed away before the 6 month study visit. | Posted | Count of Participants | Participants | measured at 6 months and 1 year post-ablation |
|
| |||||||||||||||||||||||||||
| Secondary | Number of Patients Who Were Readmitted to the Hospital | Any readmission to the hospital within 30 days of the ablation procedure. | Posted | Count of Participants | Participants | Within 30 days post-ablation |
|
| ||||||||||||||||||||||||||||
| Primary | User Experience Survey (Part I) | A Sponsor-created survey completed by the treating physician immediately post-ablation. Questions were all YES/NO. | Posted | Count of Participants | Participants | Immediately post-ablation |
|
| ||||||||||||||||||||||||||||
| Primary | 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. | Posted | Mean | Standard Deviation | Minutes | Immediately post-ablation |
|
| |||||||||||||||||||||||||||
| Primary | 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. | Posted | Mean | Standard Deviation | Count of Scans | Immediately post-ablation |
|
| |||||||||||||||||||||||||||
| Primary | 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. | Posted | Mean | Standard Deviation | Millimeters | Immediately post-ablation |
|
| |||||||||||||||||||||||||||
| Primary | 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. | Posted | Mean | Standard Deviation | Count of Probe Repositions | Immediately post-ablation |
|
|
1 year following the initial ablation procedure.
Participants were evaluated for AEs and SAEs at every study visit starting with the ablation procedure through the end-of-study (1 year following the initial ablation procedure).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Microwave Ablation | Each participant underwent microwave ablation to the original soft tissue lesion in the lung at single visit. The treating physician determined the ablation time and power used on a case-by-case basis. | 2 | 10 | 3 | 10 | 9 | 10 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ataxia | Nervous system disorders | MedDRA pref. term | Non-systematic Assessment | worsening ataxia symptoms |
|
| Chronic Obstructive Pulmonary Disease | Respiratory, thoracic and mediastinal disorders | MedDRA pref. term | Non-systematic Assessment | worsening or flare-up of pre-existing condition. |
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| Infected Bite | Infections and infestations | MedDRA pref. term | Non-systematic Assessment | cellulitis of the right hand from infected cat bite. |
|
| Haemorrhage | Vascular disorders | MedDRA pref. term | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA pref. term | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA pref. term | Non-systematic Assessment |
| |
| Chronic Obstructive Pulmonary Disease | Respiratory, thoracic and mediastinal disorders | MedDRA pref. term | Non-systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | MedDRA pref. term | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA pref. term | Non-systematic Assessment |
| |
| Musculoskeletal Chest Pain | Musculoskeletal and connective tissue disorders | MedDRA pref. term | Non-systematic Assessment |
| |
| Musculoskeletal Pain | Musculoskeletal and connective tissue disorders | MedDRA pref. term | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA pref. term | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA pref. term | Non-systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Erin Meyers | ETHICON | 937-681-0322 | eprifog1@its.jnj.com |
| SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol | Jul 25, 2018 | Sep 22, 2020 | Prot_001.pdf |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Non-Smoker |
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| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
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| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| Probe through channel as expected |
| |||||
| Probe repositioned after first ablation |
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| Ablation with NeuWave is predictable |
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| Ablation with FLEX is simple to use |
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| Success achieved similar to perc. |
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| Locate probe/lesion with imaging |
| |||||
| Locate ablation zone created |
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| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
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| Title | Denominators | Categories | ||||
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