Clinical trial · Interventional
Vapor Ablation for Localized Cancer Lesions of the Lung (VAPORIZE)
Vapor Ablation for Localized Cancer Lesions of the Lung - A Clinical Feasibility Treat-and Resect Study (VAPORIZE)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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 inclusion criteria and none of the exclusion criteria will receive vapor ablation treatment. Patients will receive BTVA-C treatment followed by standard-of-practice surgical resection.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
| Metastatic Lung Cancer | Malignant Lung Neoplasm | CURATED_BROADER | 0.78 |
| Non Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bronchoscopic Thermal Vapor Ablation | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Vapor Ablation
- interventionNames
- Device: Bronchoscopic Thermal Vapor Ablation
Primary outcomes (4)
- measure
- AEs and SAEs related to BTVA-C procedure
- timeFrame
- Day 30 follow-up
- description
- The number of reported adverse events (AEs), serious adverse events (SAEs) related to the BTVA-C procedure.
- measure
- Successful BTVA-C Treatment Delivery
- timeFrame
- 1 day post-ablation
- description
- 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 navigational plan
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age: ≥ 18 years old 2. Non-small cell lung cancer tumor(s) ≤ 2cm (T1aN0, T1bN0, T1aN1, or T1bN1) suitable for resection OR Metastatic lung tumor(s) ≤ 2cm suitable for resection 3. Suitable candidate for resection per standard of practice 4. Microscopic proof of malignancy obtained. 5. Location of tumor: 1. In periphery of lung (outermost 1/3) 2. Anticipation that resection would remove all gross tumor and ablation with grossly negative margins 3. Maximum of three vapor ablation applications would target entire margin according to the vapor ablation plan 6. Signed informed consent Exclusion Criteria: 1. Centralized tumor not amenable to resection (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) or forced vital capacity (FVC) \< 50% predicted, diffusing capacity of the lung for carbon monoxide (DLCO) \<50% predicted 5. Requirement for supplemental oxygen at rest or 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. 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
References
Publications (0)
Data not yet available