Non Small Cell Lung CancerVAPORIZEDNCT03514329
Vapor Ablation for Localized Cancer Lesions
A study testing Bronchoscopic Thermal Vapor Ablation in people with Non Small Cell Lung Cancer and Metastatic Lung Cancer, run by Uptake Medical Technology, Inc. at 2 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Small Cell Lung Cancer, Metastatic Lung Cancer, Lung Cancer
- What is being tested?
- Bronchoscopic Thermal Vapor Ablation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 1 Sep 2026to 30 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Centralized tumor (abutting main stem bronchus, main pulmonary artery branches, esophagus, or trachea)
- Carcinoid lung tumors
- Tumor is associated with atelectasis or obstructive pneumonitis or pleural effusion
- 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)
- Hospitalization for cardiac disease within the preceding 6 months
Show all 15Show fewer
- Liver enzymes (ALP, ALT, AST) or total bilirubin > 1.5 upper limit of normal (ULN)
- Serum creatinine > 2 mg/dl
- Recent infection (within 30 days)
- Currently receiving immunosuppressive medication or prednisone > 10 mg/day (or equivalent)
- Pre-existing implants within the airways that impede navigation to the target lesion
- Pregnant or breastfeeding women and those of childbearing potential who are not practicing a reliable form of contraception.
- 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.
- 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
- 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.
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
Austria1 site
Otto-Wagner Hospital
Vienna
Marina Duller, blvr.koordinator@gmail.com
Arschang Valipour, MD
Italy1 site
Azienda Ospedaliero - Universitaria
Ancona, I-60020
Martina Bonifazi, MD, martinabonifazi@libero.it
Stefano Gasparini, MD
About this study
Official 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.
Read the detailed 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.
Subjects identified for this study will be those that have microscopic proof of malignancy. Patients who have consented to participate in this study (enrolled) will undergo screening assessments to evaluate the inclusion criteria associated with their lung cancer and general health. Only patients that meet all of the inclusion criteria and none of the exclusion criteria will be scheduled for treatment with the BTAV-C System.
A total of 10 subjects will be treated at up to 3 investigational sites within the EU.
Prior to the vapor ablation procedure, the patient's CT scan is analyzed to evaluate the location and size of the target lesion. The segments and airways associated with the lesion are identified and images are created to aid in the navigation to appropriate treatment locations during the upcoming procedure.
At the time of the vapor ablation procedure, the Uptake catheter is placed in a selected airway with a thin bronchoscope. A balloon at the distal end of the catheter is then inflated to occlude the bronchus prior to vapor infusion. Sterile water is heated to approximately 100° - 140°C by a reusable generator and vapor (steam) is infused into the targeted region for 8 seconds at a precisely controlled flow rate and power. If necessary, the catheter is moved to the next airway and the procedure is repeated until all desired airways have been treated (maximum 3 treatments). The treatment creates a uniform field of necrosis in the parenchyma around the lesion.
Patients will be evaluated for clinical symptoms in the 30-day period following ablation. Local control of the tumor will be evaluated based on Response Evaluation Criteria in Solid Tumors (RECIST) from low dose CT scans at 1, 3, 6 and 12 months following ablation.
- Being tested
- Bronchoscopic Thermal Vapor Ablation
- Keywords
- Non Small Cell Lung Cancer, Metastatic Lung Cancer, Lung Cancer, Vapor Ablation, BTVA
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bronchoscopic Thermal Vapor AblationDevice
Also called BTVA-C
Vapor (steam) is infused into the targeted region for 8 seconds at a precisely controlled flow rate and power.
| Study group | Role | What they receive |
|---|---|---|
| Vapor Ablation | Experimental | Patients treated with Bronchoscopic Thermal Vapor Ablation for lung cancer Receives: Device: Bronchoscopic Thermal Vapor Ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
BTVA-C related AEs/SAEs
The number of reported adverse events (AEs), serious adverse events (SAEs) related to the BTVA-C procedure.
Measured: up to 6 months post-ablation
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
Measured: Day 0
Local Control Evaluation per RECIST
Evaluation in the change in response to vapor ablation based on the RECIST 1.1 protocol
Measured: Month 1, 3, 6, and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2018
- Study start1 Sep 2026 (estimated)
- Primary completion30 Mar 2028 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Uptake Medical Technology, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03514329
- Sponsor's protocol ID
- CSP-2315
- Acronym
- VAPORIZED
- Status last verified
- Feb 2025
- First submitted
- 25 Sep 2017
- Last updated
- 27 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vapor Ablation for Localized Cancer Lesions of the Lung - A Clinical Feasibility Definitive Treatment Study
- ClinicalTrials.gov ID
- NCT03514329
- Acronym / sponsor ID
- VAPORIZED / CSP-2315
- Keywords
- Non Small Cell Lung Cancer, Metastatic Lung Cancer, Lung Cancer, Vapor Ablation, BTVA
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Uptake Medical Technology, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 30 Mar 2028 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 2 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Subjects identified for this study will be those that have microscopic proof of malignancy. Patients who have consented to participate in this study (enrolled) will undergo screening assessments to evaluate the inclusion criteria associated with their lung cancer and general health. Only patients that meet all of the inclusion criteria and none of the exclusion criteria will be scheduled for treatment with the BTAV-C System.
A total of 10 subjects will be treated at up to 3 investigational sites within the EU.
Prior to the vapor ablation procedure, the patient's CT scan is analyzed to evaluate the location and size of the target lesion. The segments and airways associated with the lesion are identified and images are created to aid in the navigation to appropriate treatment locations during the upcoming procedure.
At the time of the vapor ablation procedure, the Uptake catheter is placed in a selected airway with a thin bronchoscope. A balloon at the distal end of the catheter is then inflated to occlude the bronchus prior to vapor infusion. Sterile water is heated to approximately 100° - 140°C by a reusable generator and vapor (steam) is infused into the targeted region for 8 seconds at a precisely controlled flow rate and power. If necessary, the catheter is moved to the next airway and the procedure is repeated until all desired airways have been treated (maximum 3 treatments). The treatment creates a uniform field of necrosis in the parenchyma around the lesion.
Patients will be evaluated for clinical symptoms in the 30-day period following ablation. Local control of the tumor will be evaluated based on Response Evaluation Criteria in Solid Tumors (RECIST) from low dose CT scans at 1, 3, 6 and 12 months following ablation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vapor Ablation | Experimental | Device: Bronchoscopic Thermal Vapor AblationPatients treated with Bronchoscopic Thermal Vapor Ablation for lung cancer |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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:
Key exclusion criteria (15 listed)
- Centralized tumor (abutting main stem bronchus, main pulmonary artery branches, esophagus, or trachea)
- Carcinoid lung tumors
- Tumor is associated with atelectasis or obstructive pneumonitis or pleural effusion
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bronchoscopic Thermal Vapor AblationAlso: BTVA-CVapor (steam) is infused into the targeted region for 8 seconds at a precisely controlled flow rate and power. | Device | Vapor Ablation |
Primary outcome
BTVA-C related AEs/SAEs
Time frame: up to 6 months post-ablation
The number of reported adverse events (AEs), serious adverse events (SAEs) related to the BTVA-C procedure.
Successful BTVA-C Treatment Delivery
Time frame: Day 0
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
Local Control Evaluation per RECIST
Time frame: Month 1, 3, 6, and 12
Evaluation in the change in response to vapor ablation based on the RECIST 1.1 protocol
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2025.
- Uptake Medical websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bronchoscopic Thermal Vapor Ablation in people with Non Small Cell Lung Cancer and Metastatic Lung Cancer, run by Uptake Medical Technology, Inc. at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Austria, Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gheda Sahyun (650-823-9093, gsahyun@broncus.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BTVA-C related AEs/SAEs (time frame: up to 6 months post-ablation). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2025.