Non Small Cell Lung CancerVAPORIZENCT03198468
Vapor Ablation for Localized Cancer Lesions of the Lung (VAPORIZE)
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 1 site in Australia.
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
- 8 participants
- Where
- 1 siteAustralia
- Study dates
- 21 Nov 2018to 20 Aug 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- 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
- Suitable candidate for resection per standard of practice
- Microscopic proof of malignancy obtained.
- Location of tumor:
- In periphery of lung (outermost 1/3)
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- Anticipation that resection would remove all gross tumor and ablation with grossly negative margins
- Maximum of three vapor ablation applications would target entire margin according to the vapor ablation plan
- Signed informed consent
Who cannot join
- Centralized tumor not amenable to resection (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) or forced vital capacity (FVC) < 50% predicted, diffusing capacity of the lung for carbon monoxide (DLCO) <50% predicted
- Requirement for supplemental oxygen at rest or exercise
- Hospitalization for cardiac disease within the preceding 6 months
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- 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)
- 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
1 site in 1 country.
About this study
Official title: Vapor Ablation for Localized Cancer Lesions of the Lung - A Clinical Feasibility Treat-and Resect Study (VAPORIZE)
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.
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 a surgical resection already scheduled as part of their lung cancer treatment. 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 BTVA-C System.
A total of 8 subjects will be treated at up to 2 investigational sites in Australia.
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.
The interval between vapor ablation and the surgical resection will be a minimum of 60 hours to a maximum of 105 hours, with the exact scheduling determined by the investigator. The resected tissue will undergo pathological evaluation for tissue viability.
In addition to standard post-operative follow-up, patients will be evaluated at Day 7 (± 2 days) and Day 30 (± 5 days) post-resection to assess safety and feasibility.
- 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
Vapor (steam) is infused into the targeted region for 8 seconds at a precisely controlled flow rate and power (an energy level of 330 calories).
| Study group | Role | What they receive |
|---|---|---|
| Vapor Ablation | Experimental | Not described Receives: Device: Bronchoscopic Thermal Vapor Ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
AEs and SAEs related to BTVA-C procedure
The number of reported adverse events (AEs), serious adverse events (SAEs) related to the BTVA-C procedure.
Measured: Day 30 follow-up
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 navigational plan
Measured: 1 day post-ablation
Ischemic tissue assessment
CT Imaging to identify and assess ischemic tissue
Measured: 2-4 days post-ablation (pre surgical resection)
Tissue necrosis evaluated by semi-quantitative histological analysis
Semi-quantitative scoring of necrotic tissue assessed by histology
Measured: 1 day post-surgical resection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2017
- Study start21 Nov 2018
- Primary completion20 Aug 2019
- Study completion20 Aug 2019
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
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uptake Medical Technology, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Daniel Steinfort, MD, PhD, Principal investigator, Melbourne Health, The Royal Melbourne Hospital, City Campus.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03198468
- Sponsor's protocol ID
- CSP-2402
- Acronym
- VAPORIZE
- Status last verified
- Nov 2021
- First submitted
- 14 Jun 2017
- Last updated
- 15 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2021. 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 Treat-and Resect Study (VAPORIZE)
- ClinicalTrials.gov ID
- NCT03198468
- Acronym / sponsor ID
- VAPORIZE / CSP-2402
- Keywords
- Non Small Cell Lung Cancer, Metastatic Lung Cancer, Lung Cancer, Vapor Ablation, BTVA
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Uptake Medical Technology, Inc.Industry (pharma, biotech, devices)
- Study start
- 21 Nov 2018 (actual)
- Primary completion
- 20 Aug 2019 (actual)
- Study completion
- 20 Aug 2019 (actual)
- First posted
- 26 Jun 2017 (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 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.
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 a surgical resection already scheduled as part of their lung cancer treatment. 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 BTVA-C System.
A total of 8 subjects will be treated at up to 2 investigational sites in Australia.
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.
The interval between vapor ablation and the surgical resection will be a minimum of 60 hours to a maximum of 105 hours, with the exact scheduling determined by the investigator. The resected tissue will undergo pathological evaluation for tissue viability.
In addition to standard post-operative follow-up, patients will be evaluated at Day 7 (± 2 days) and Day 30 (± 5 days) post-resection to assess safety and feasibility.
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 Ablation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age: ≥ 18 years old
- 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
- Suitable candidate for resection per standard of practice
- Microscopic proof of malignancy obtained.
- Location of tumor:
Key exclusion criteria (15 listed)
- Centralized tumor not amenable to resection (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) or forced vital capacity (FVC) < 50% predicted, diffusing capacity of the lung for carbon monoxide (DLCO) <50% predicted
- Requirement for supplemental oxygen at rest or 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 AblationVapor (steam) is infused into the targeted region for 8 seconds at a precisely controlled flow rate and power (an energy level of 330 calories). | Device | Vapor Ablation |
Primary outcome
AEs and SAEs related to BTVA-C procedure
Time frame: Day 30 follow-up
The number of reported adverse events (AEs), serious adverse events (SAEs) related to the BTVA-C procedure.
Successful BTVA-C Treatment Delivery
Time frame: 1 day post-ablation
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
Ischemic tissue assessment
Time frame: 2-4 days post-ablation (pre surgical resection)
CT Imaging to identify and assess ischemic tissue
Tissue necrosis evaluated by semi-quantitative histological analysis
Time frame: 1 day post-surgical resection
Semi-quantitative scoring of necrotic tissue assessed by histology
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2021.
- 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. This study is not recruiting at the moment.
Daniel Steinfort, MD, PhD principal investigator
Melbourne Health, The Royal Melbourne Hospital, City Campus.
1 site in 1 country: 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 1 site in Australia.
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 9 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: finished, as of the sponsor's last update on 15 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AEs and SAEs related to BTVA-C procedure (time frame: Day 30 follow-up). The study lists 4 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 15 Nov 2021.