Vapor Ablation for Localized Cancer Lesions of the Lung – A Clinical Feasibility Treat-and-Resect Study (VAPORIZE)
Uptake Medical Inc.
6 participants
Dec 14, 2018
Interventional
Conditions
Summary
The purpose of this study is to examine the feasibility and safety of a device for ablating cancerous lung tumors using a technique called thermal vapor ablation. Who is it for? You may be eligible for this study if you are aged 18 or older and are a suitable candidate for resection of a lung cancer tumor. Study details All participants will receive one treatment of thermal vapor ablation via a bronchoscope (tube down the throat), 2-4 days before undergoing their scheduled surgical lung resection. The treatment takes place under general anaesthetic in a day surgery procedure area. All participants will be followed-up using standard hospital procedures. It is hoped that this research will provide information into the non-surgical treatments of lung cancer, thereby providing future non-surgery related options for the disease.
Eligibility
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Interventions
Thermal Vapor Ablation delivered to target lung areas (Cancerous Lesions). Thermal Vapor Ablation involves the delivery of a measured dose boiling water to the area surrounding the cancerous lesion. The Vapor ablation will be delivered by an interventional pulmonologist (respiratory physician) in a bronchoscopy suite within a hospital. One dose of 330 calories of energy is delivered to targeted lung lesions (according to a CT guided therapy plan) during a single bronchoscopic procedure prior to lung resection. This procedure will generally take less than 30 minutes to perform. Lung resection will then occur according to the standard hospital procedures. Subjects will be treated with Thermal Vapor Ablation (BTVA-C) and the interval between ablation and resection will be a minimum of 60 hours to a maximum of 105 hours, with the exact scheduling determined by the investigator.
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ACTRN12618001748202