This is a prospective, multicenter, single-arm study on transbronchial microwave ablation using the NEUWAVE FLEX Microwave Ablation System and Accessories on oligometastatic tumors in the peripheral lung, guided by the Auris MONARCH Platform for visualization and access while using cone beam CT (computed tomography) to confirm probe tip placement and final ablation zone. The primary endpoint is Technique Efficacy, assessed 30-days post-ablation via CT imaging.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
12
Transbronchial microwave ablation will be performed using the NEUWAVE FLEX Microwave Ablation System and Accessories on oligometastatic tumors in the peripheral lung, guided by the Auris MONARCH Platform for visualization and access while using cone beam CT (computed tomography) to confirm probe tip placement and final ablation zone.
Stanford University School of Medicine
Stanford, California, United States
UCONN Health
Farmington, Connecticut, United States
Minnesota Lung Center
Minneapolis, Minnesota, United States
Number of Patients Whose Ablation Resulted in Technique Efficacy
Technique Efficacy is defined as ablation of the target tumor(s) with the ablation zone completely overlapping or encompassing the entire target tumor(s) as assessed using CT imaging 30 days (- 7 to +14 days) after the ablation procedure.
Time frame: 30 days post-ablation
Number of Patients Whose Ablation Resulted in Technical Success
Technical Success is defined as ablation of the target lesion(s) according to the protocol and covered completely, with an adequate margin (that is, the ablation zone completely overlaps or encompasses the target lesion plus an ablative margin), as assessed by the performing physician using CBCT imaging, immediately following the procedure.
Time frame: Immediately post-ablation (Day 0)
Number of Patients Who Experienced Local Tumor Progression
Local Tumor Progression, or recurrence of the originally ablated tumor(s) within or abutting the ablation zone, using the 30 day post-ablation imaging as baseline, was analyzed at 3 months, 6 months and 1 year post-ablation via CT imaging
Time frame: Assessed at 3 months, 6 months and 1 year post-ablation
Number of Patients Who Experienced Disease Progression
Disease Progression includes local tumor progression (that is, recurrence of the target ablated tumor within or abutting the ablation zone) and regional tumor progression (that is, new or progression of non-ablated pre-existing tumors within the lung but outside the ablation zone) and distant tumor progression. Results for each category (local, regional, and distant tumor progression) are specified, as well as Overall Disease Progression. Disease Progression was analyzed at 3 months, 6 months and 1 year post-ablation via CT imaging as per treating physician assessment
Time frame: Assessed at 3 months, 6 months and 1 year post-ablation
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FirstHealth Moore Regional Hospital
Pinehurst, North Carolina, United States
Cleveland Clinic
Cleveland, Ohio, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
MD Anderson
Houston, Texas, United States
University of Toronto
Toronto, Ontario, Canada
Centre Hospitalier de l'Universite de Montreal
Montreal, Quebec, Canada
Prince of Wales Hospital
Shatin, Hong Kong
Number of Patients Who Required Repeat Ablation of Target Lesion
Number of patients that experienced a recurrence of the successfully ablated target lesion, as assessed at Day 30 post-ablation, and underwent a repeat ablation of the target Lesion
Time frame: Assessed at 3 months, 6 months and 1 year post-ablation