Vapor Ablation for Localized Cancer Lesions

Launched by UPTAKE MEDICAL TECHNOLOGY, INC. · Apr 30, 2018

Keywords

ClinConnect Summary

This clinical trial is investigating a new procedure called Bronchoscopic Thermal Vapor Ablation (BTVA-C) for treating localized lung cancer, specifically focusing on patients with non-small cell lung cancer or metastatic lung cancer. The goal is to see if this method can effectively target and treat small tumors in the lungs, which are generally up to 2 centimeters in size. To participate, patients need to be at least 18 years old and have tumors located in the outer part of the lung, among other specific eligibility criteria.

Participants in the trial will undergo some initial health assessments to ensure they qualify for the treatment. If they meet all the necessary requirements, they will receive the vapor ablation procedure and will be monitored for up to 12 months afterward. It’s important to note that this trial is not yet recruiting participants, but it aims to explore a promising alternative for patients who may not be candidates for traditional surgery. Patients and their families can expect close follow-up care and support throughout the study.

Gender

ALL

Eligibility criteria

• 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.