Vapor Ablation for Localized Cancer Lesions of the Lung (VAPORIZE)
NCT ID: NCT03198468
Last Updated: 2021-11-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
8 participants
INTERVENTIONAL
2018-11-21
2019-08-20
Brief Summary
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Patients will receive BTVA-C treatment followed by standard-of-practice surgical resection.
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Vapor Ablation
Bronchoscopic Thermal Vapor Ablation
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).
Interventions
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Bronchoscopic Thermal Vapor Ablation
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).
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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Uptake Medical Technology, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Daniel Steinfort, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Melbourne Health, The Royal Melbourne Hospital, City Campus.
Locations
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The Royal Melbourne Hospital
Melbourne, Victoria, Australia
Countries
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Related Links
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Uptake Medical Website
Other Identifiers
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CSP-2402
Identifier Type: -
Identifier Source: org_study_id