Vapor Ablation for Localized Cancer Lesions (NCT03514329) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Vapor Ablation for Localized Cancer Lesions
Austria, Italy10 participantsStarted 2026-09-01
Plain-language summary
This study is a prospective, single-arm, multi-center, pilot trial of Bronchoscopic Thermal Vapor Ablation for Lung Cancer (BTVA-C) in patients with primary lung cancer or metastatic cancer in the lung. Patients who have consented to participate in this study (enrolled) will be subject to eligibility screening and baseline assessments, prior to undergoing the BTVA-C procedure. Only patients that meet all of the inclusion criteria and none of the exclusion criteria will receive vapor ablation treatment.
Patients will be followed for up to 12 months.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Age: ≥ 18 years old
✓. Patient has been recommended for ablation or recommended for an alternative to surgery
✓. Non-small cell lung cancer tumor(s) ≤ 2cm (T1aN0, T1bN0) OR Metastatic lung tumor(s) ≤ 2cm
✓. Microscopic proof of malignancy obtained
✓. Location of tumor:
✓. In periphery of lung (outermost 1/3)
✓. Maximum of three vapor ablation applications would target entire margin according to the vapor ablation plan
✓. Signed patient informed consent
Exclusion criteria
✕. Centralized tumor (abutting main stem bronchus, main pulmonary artery branches, esophagus, or trachea)
. Tumor is associated with atelectasis or obstructive pneumonitis or pleural effusion
✕. Pulmonary function tests (PFTs): post-bronchodilator forced expired volume in one second (FEV1) \<20% predicted, diffusing capacity of the lung for carbon monoxide (DLCO)\<20% predicted
✕. Requirement for supplemental oxygen (includes at rest or during exercise)
✕. Hospitalization for cardiac disease within the preceding 6 months
✕. Liver enzymes (ALP, ALT, AST) or total bilirubin \> 1.5 upper limit of normal (ULN)