Lung Cancer Clinical Trial
— VAPORIZEDOfficial title:
Vapor Ablation for Localized Cancer Lesions of the Lung - A Clinical Feasibility Definitive Treatment Study
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.
Status | Not yet recruiting |
Enrollment | 10 |
Est. completion date | June 30, 2026 |
Est. primary completion date | March 30, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Age: = 18 years old 2. Patient has been recommended for ablation or recommended for an alternative to surgery 3. Non-small cell lung cancer tumor(s) = 2cm (T1aN0, T1bN0) OR Metastatic lung tumor(s) = 2cm 4. Microscopic proof of malignancy obtained 5. Location of tumor: 1. In periphery of lung (outermost 1/3) 2. Maximum of three vapor ablation applications would target entire margin according to the vapor ablation plan 6. Signed patient informed consent Exclusion Criteria: 1. Centralized tumor (abutting main stem bronchus, main pulmonary artery branches, esophagus, or trachea) 2. Carcinoid lung tumors 3. Tumor is associated with atelectasis or obstructive pneumonitis or pleural effusion 4. 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 5. Requirement for supplemental oxygen (includes at rest or during exercise) 6. Hospitalization for cardiac disease within the preceding 6 months 7. Liver enzymes (ALP, ALT, AST) or total bilirubin > 1.5 upper limit of normal (ULN) 8. Serum creatinine > 2 mg/dl 9. Recent infection (within 30 days) 10. Currently receiving immunosuppressive medication or prednisone > 10 mg/day (or equivalent) 11. Pre-existing implants within the airways that impede navigation to the target lesion 12. Pregnant or breastfeeding women and those of childbearing potential who are not practicing a reliable form of contraception. 13. Disorder of coagulation, history of severe hemoptysis, or receiving anticoagulant medication. Antiplatelet medication is permitted provided that the medication can be held a minimum of 7 days prior to the procedure and 10 days post-procedure. 14. Any condition that in the opinion of the investigator or reviewer may interfere with the safety of the patient or evaluation of the study objectives 15. Any tumor characteristic that in the opinion of the investigator or reviewers may interfere with the safety of the patient or evaluation of the study objectives. |
Country | Name | City | State |
---|---|---|---|
Austria | Otto-Wagner Hospital | Vienna | |
Italy | Azienda Ospedaliero - Universitaria | Ancona |
Lead Sponsor | Collaborator |
---|---|
Uptake Medical Technology, Inc. |
Austria, Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | BTVA-C related AEs/SAEs | The number of reported adverse events (AEs), serious adverse events (SAEs) related to the BTVA-C procedure. | up to 6 months post-ablation | |
Primary | Successful BTVA-C Treatment Delivery | Treatment meets 100% of the required procedural steps/requirements per the Instructions for Use (IFU) and treatment is delivered to the target tumor per the individual patient navigation plan | Day 0 | |
Primary | Local Control Evaluation per RECIST | Evaluation in the change in response to vapor ablation based on the RECIST 1.1 protocol | Month 1, 3, 6, and 12 |
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