NCT03514329Not yet recruiting
Vapor Ablation for Localized Cancer Lesions
Vapor Ablation for Localized Cancer Lesions of the Lung - A Clinical Feasibility Definitive Treatment Study
Source: ClinicalTrials.gov · Last updated 27 Feb 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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 (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 10 (estimated)
- First submitted
- 25 Sept 2017
- Start date
- 1 Sept 2026
- Primary completion date
- 30 Mar 2028
- Lead sponsor
- Uptake Medical Technology, Inc.
- Diseases
- Lung cancer
- NCT number
- NCT03514329
What you commit to
- Study type: Interventional
- Planned participants: 10
- From 1 Sept 2026 to the primary completion date, 30 Mar 2028
- 2 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- 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
Lab values
- Liver enzymes (ALP, ALT, AST) or total bilirubin \> 1.5 upper limit of normal (ULN)
- Serum creatinine \> 2 mg/dl
Other
- 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.
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Otto-Wagner Hospital Coordinator of this site? Confirm its status | Vienna | Austria | Unknown status |
| Azienda Ospedaliero - Universitaria Coordinator of this site? Confirm its status | Ancona | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.