Vapor Ablation for Localized Cancer Lesions (VAPORIZED)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03514329|
Recruitment Status : Not yet recruiting
First Posted : May 2, 2018
Last Update Posted : November 5, 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 the inclusion criteria and none of the exclusion criteria will receive vapor ablation treatment.
Patients will be followed for up to 12 months.
|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 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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Vapor Ablation for Localized Cancer Lesions of the Lung - A Clinical Feasibility Definitive Treatment Study|
|Estimated Study Start Date :||April 1, 2020|
|Estimated Primary Completion Date :||December 30, 2020|
|Estimated Study Completion Date :||March 30, 2021|
Experimental: Vapor Ablation
Patients treated with Bronchoscopic Thermal Vapor Ablation for lung cancer
Device: Bronchoscopic Thermal Vapor Ablation
Vapor (steam) is infused into the targeted region for 8 seconds at a precisely controlled flow rate and power.
Other Name: BTVA-C
- 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
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): NCT03514329
|Contact: Pam Ninnemanemail@example.com|
|Contact: Julie Arnesonfirstname.lastname@example.org|
|Otto-Wagner Hospital||Not yet recruiting|
|Contact: Marina Duller email@example.com|
|Principal Investigator: Arschang Valipour, MD|
|Azienda Ospedaliero - Universitaria||Recruiting|
|Ancona, Italy, I-60020|
|Contact: Martina Bonifazi, MD firstname.lastname@example.org|
|Principal Investigator: Stefano Gasparini, MD|