Tests heat vapor treatment through a bronchoscope for lung cancer lesions
Tests heat vapor ablation through a bronchoscope in adults with lung cancer.
Plain-language title generated from the registry record
Registry title: Vapor Ablation for Localized Cancer Lesions
Key facts
- Where
- Vienna, AustriaSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Which best describes your lung cancer?
Source: NCT03514329, who can take part
Where in Austria
- Otto-Wagner HospitalVienna, AustriaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Uptake Medical Technology, Inc.
- Trial code
- NCT03514329
- Record updated
- 27 February 2025
- Original description
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.Read full original descriptionShow less
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.
Inclusion: 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: Currently receiving immunosuppressive medication or prednisone > 10 mg/day (or equivalent); Pre-existing implants within the airways that impede navigation to the target lesion; 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; Tumor is associated with atelectasis or obstructive pneumonitis or pleural effusion; Hospitalization for cardiac disease within the preceding 6 months; Recent infection (within 30 days); 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; Liver enzymes (ALP, ALT, AST) or total bilirubin > 1.5 upper limit of normal (ULN); Serum creatinine > 2 mg/dl; Centralized tumor (abutting main stem bronchus, main pulmonary artery branches, esophagus, or trachea); Carcinoid lung tumors; 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); Pregnant or breastfeeding women and those of childbearing potential who are not practicing a reliable form of contraception; 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.