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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03198468




Registration number
NCT03198468
Ethics application status
Date submitted
14/06/2017
Date registered
26/06/2017

Titles & IDs
Public title
Vapor Ablation for Localized Cancer Lesions of the Lung (VAPORIZE)
Scientific title
Vapor Ablation for Localized Cancer Lesions of the Lung - A Clinical Feasibility Treat-and Resect Study (VAPORIZE)
Secondary ID [1] 0 0
CSP-2402
Universal Trial Number (UTN)
Trial acronym
VAPORIZE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non Small Cell Lung Cancer 0 0
Metastatic Lung Cancer 0 0
Lung Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Mesothelioma
Cancer 0 0 0 0
Lung - Non small cell
Cancer 0 0 0 0
Lung - Small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Bronchoscopic Thermal Vapor Ablation

Experimental: Vapor Ablation -


Treatment: Devices: 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).
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
AEs and SAEs related to BTVA-C procedure
Timepoint [1] 0 0
Day 30 follow-up
Primary outcome [2] 0 0
Successful BTVA-C Treatment Delivery
Timepoint [2] 0 0
1 day post-ablation
Primary outcome [3] 0 0
Ischemic tissue assessment
Timepoint [3] 0 0
2-4 days post-ablation (pre surgical resection)
Primary outcome [4] 0 0
Tissue necrosis evaluated by semi-quantitative histological analysis
Timepoint [4] 0 0
1 day post-surgical resection

Eligibility
Key inclusion criteria
1. Age: = 18 years old
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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Centralized tumor not amenable to resection (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) 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
21/11/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
20/08/2019
Sample size
Target
Accrual to date
Final
8
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
The Royal Melbourne Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
3050 - Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Uptake Medical Technology, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Daniel Steinfort, MD, PhD
Address 0 0
Melbourne Health, The Royal Melbourne Hospital, City Campus.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT03198468