RecruitingACTRN12618001748202

Vapor Ablation for Localized Cancer Lesions of the Lung – A Clinical Feasibility Treat-and-Resect Study (VAPORIZE)


Sponsor

Uptake Medical Inc.

Enrollment

6 participants

Start Date

Dec 14, 2018

Study Type

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

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This study is exploring a new way to treat small lung cancer tumours without traditional surgery, using a technique called thermal vapour ablation. In this approach, a thin tube called a bronchoscope is passed down the throat into the airway, and controlled bursts of steam are delivered directly to the tumour to destroy it. Because the procedure is done through the airways rather than through cuts in the chest, it has the potential to be much less invasive than surgery. To test how well the ablation works, participants receive the vapour treatment 2–4 days before their already-planned surgical tumour removal. This allows researchers to directly examine the treated tissue under a microscope and see how effectively the vapour destroyed the cancer cells. You may be eligible if you are 18 or older, have a small non-small cell lung cancer tumour (2 cm or less in diameter) or a metastatic lung tumour of similar size located in the outer third of the lung, and are already scheduled for surgical removal of that tumour. People with very reduced lung function, active heart disease, or certain other medical conditions are not eligible.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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.

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.


Locations(1)

Royal Melbourne Hospital - City campus - Parkville

NSW,VIC, Australia

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ACTRN12618001748202