Vapor Ablation for Localized Cancer Lesions of the Lung (VAPORIZE) (VAPORIZE)
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|ClinicalTrials.gov Identifier: NCT03198468|
Recruitment Status : Recruiting
First Posted : June 26, 2017
Last Update Posted : November 4, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Non Small Cell Lung Cancer Metastatic Lung Cancer Lung Cancer||Device: Bronchoscopic Thermal Vapor Ablation||Not Applicable|
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 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 Canada.
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, functional and clinical status.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||8 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Vapor Ablation for Localized Cancer Lesions of the Lung - A Clinical Feasibility Treat-and Resect Study (VAPORIZE)|
|Actual Study Start Date :||December 1, 2018|
|Estimated Primary Completion Date :||November 30, 2019|
|Estimated Study Completion Date :||February 28, 2020|
|Experimental: Vapor Ablation||
Device: Bronchoscopic Thermal Vapor Ablation
Vapor (steam) is infused into the targeted region for 8 seconds at a precisely controlled flow rate and power
- BTVA-C related AEs/SAEs [ 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03198468
|Contact: Pam Ninnemanemail@example.com|
|Contact: Julie Arnesonfirstname.lastname@example.org|
|Australia, New South Wales|
|Macquarie University Hospital||Not yet recruiting|
|Sydney, New South Wales, Australia, 2109|
|Contact: Radhika Butala +61 2 9812 3561 radhika@email@example.com|
|Principal Investigator: Daniel A Ing, MD, PhD|
|The Royal Melbourne Hospital||Recruiting|
|Melbourne, Victoria, Australia, 3050|
|Contact: Casey McLeod +61 437 440 251 firstname.lastname@example.org|
|Principal Investigator: Daniel Steinfort, MD, PhD|