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

Sponsor

Uptake Medical Technology, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT03198468

Collaborator

(none)

Enrollment

Location

Arm

8.9

Actual Duration (Months)

0.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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	N/A

Detailed Description

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

8 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Nov 21, 2018

Actual Primary Completion Date :

Aug 20, 2019

Actual Study Completion Date :

Aug 20, 2019

Arms and Interventions

Arm	Intervention/Treatment
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 (an energy level of 330 calories).

Arm

Intervention/Treatment

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 (an energy level of 330 calories).

Outcome Measures

Primary Outcome Measures

AEs and SAEs related to BTVA-C procedure [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 [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 [2-4 days post-ablation (pre surgical resection)]
CT Imaging to identify and assess ischemic tissue
Tissue necrosis evaluated by semi-quantitative histological analysis [1 day post-surgical resection]
Semi-quantitative scoring of necrotic tissue assessed by histology

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Age: ≥ 18 years old
Non-small cell lung cancer tumor(s) ≤ 2cm (T1aN0, T1bN0, T1aN1, or T1bN1) suitable for resection OR Metastatic lung tumor(s) ≤ 2cm suitable for resection
Suitable candidate for resection per standard of practice
Microscopic proof of malignancy obtained.
Location of tumor:
In periphery of lung (outermost 1/3)
Anticipation that resection would remove all gross tumor and ablation with grossly negative margins
Maximum of three vapor ablation applications would target entire margin according to the vapor ablation plan
Signed informed consent

Exclusion Criteria:

Centralized tumor not amenable to resection (abutting main stem bronchus, main pulmonary artery branches, esophagus, or trachea)
Carcinoid lung tumors
Tumor is associated with atelectasis or obstructive pneumonitis or pleural effusion
Pulmonary function tests (PFTs): post-bronchodilator forced expired volume in one second (FEV1) or forced vital capacity (FVC) < 50% predicted, diffusing capacity of the lung for carbon monoxide (DLCO) <50% predicted
Requirement for supplemental oxygen at rest or exercise
Hospitalization for cardiac disease within the preceding 6 months
Liver enzymes (ALP, ALT, AST) or total bilirubin > 1.5 upper limit of normal (ULN)
Serum creatinine > 2 mg/dl
Recent infection (within 30 days)
Receiving immunosuppressive medication or prednisone > 10 mg/day (or equivalent)
Pre-existing implants within the airways that impede navigation to the target lesion
Pregnant or breastfeeding women and those of childbearing potential who are not practicing a reliable form of contraception
Disorder of coagulation, history of severe hemoptysis, or receiving anticoagulant medication. Antiplatelet medication is permitted provided that the medication can be held a minimum of 7 days prior to the procedure and 10 days, post-procedure.
Any condition that in the opinion of the investigator or reviewer may interfere with the safety of the patient or evaluation of the study objectives
Any tumor characteristic that in the opinion of the investigator or reviewers may interfere with the safety of the patient or evaluation of the study objectives