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Respiratory Tract (Lung and Bronchial) Diseases

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Carcinoma, Non-Small-Cell Lung

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Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Patients treated with Bronchoscopic Thermal Vapor Ablation for lung cancer

Vapor (steam) is infused into the targeted region for 8 seconds at a precisely controlled flow rate and power.

Bronchoscopic Thermal Vapor Ablation

Gheda Sahyun

Marina Duller

Arschang Valipour, MD

Martina Bonifazi, MD

Stefano Gasparini, MD

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.

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.

Vapor Ablation for Localized Cancer Lesions

Vapor Ablation for Localized Cancer Lesions of the Lung - A Clinical Feasibility Definitive Treatment Study

The number of reported adverse events (AEs), serious adverse events (SAEs) related to the BTVA-C procedure.

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

Evaluation in the change in response to vapor ablation based on the RECIST 1.1 protocol

Uptake Medical Technology, Inc.

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).

Daniel Steinfort, MD, PhD

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.

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 the 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 Australia.

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 and feasibility.

Vapor Ablation for Localized Cancer Lesions of the Lung (VAPORIZE)

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

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

CT Imaging to identify and assess ischemic tissue

Semi-quantitative scoring of necrotic tissue assessed by histology

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Vapor Ablation for Localized Cancer Lesions	NCT03514329	Non Small Cell ... Metastatic Lung... Lung Cancer	Bronchoscopic T...	18 Years -	Uptake Medical Technology, Inc.
Vapor Ablation for Localized Cancer Lesions	NCT03514329	Non Small Cell ... Metastatic Lung... Lung Cancer	Bronchoscopic T...	18 Years -	Uptake Medical Technology, Inc.
Vapor Ablation for Localized Cancer Lesions of the Lung (VAPORIZE)	NCT03198468	Non Small Cell ... Metastatic Lung... Lung Cancer	Bronchoscopic T...	18 Years -	Uptake Medical Technology, Inc.
Vapor Ablation for Localized Cancer Lesions	NCT03514329	Non Small Cell ... Metastatic Lung... Lung Cancer	Bronchoscopic T...	18 Years -	Uptake Medical Technology, Inc.

Spots Global Cancer Trial Database for bronchoscopic thermal vapor ablation