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

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ClinicalTrials.gov Identifier: NCT03198468
Recruitment Status : Recruiting
First Posted : June 26, 2017
Last Update Posted : November 4, 2019
Sponsor:
Information provided by (Responsible Party):
Uptake Medical Technology, Inc.

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 Not Applicable

Detailed Description:

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 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 Canada.

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, functional and clinical status.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 8 participants
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 : December 1, 2018
Estimated Primary Completion Date : November 30, 2019
Estimated Study Completion Date : February 28, 2020

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. BTVA-C related AEs/SAEs [ Time Frame: Day 30 follow-up ]
    The number of reported adverse events (AEs), serious adverse events (SAEs) related to the BTVA-C procedure.

  2. Successful BTVA-C Treatment Delivery [ Time Frame: 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

  3. Ischemic tissue assessment [ Time Frame: 2-4 days post-ablation (pre surgical resection) ]
    CT Imaging to identify and assess ischemic tissue

  4. Tissue necrosis evaluated by semi-quantitative histological analysis [ Time Frame: 1 day post-surgical resection ]
    Semi-quantitative scoring of necrotic tissue assessed by histology



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age: ≥ 18 years old
  2. 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
  3. Suitable candidate for resection per standard of practice
  4. Microscopic proof of malignancy obtained.
  5. Location of tumor:

    1. In periphery of lung (outermost 1/3)
    2. Anticipation that resection would remove all gross tumor and ablation with grossly negative margins
    3. Maximum of three vapor ablation applications would target entire margin according to the vapor ablation plan
  6. Signed informed consent

Exclusion Criteria:

  1. Centralized tumor not amenable to resection (abutting main stem bronchus, main pulmonary artery branches, esophagus, or trachea)
  2. Carcinoid lung tumors
  3. Tumor is associated with atelectasis or obstructive pneumonitis or pleural effusion
  4. 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
  5. Requirement for supplemental oxygen at rest or exercise
  6. Hospitalization for cardiac disease within the preceding 6 months
  7. Liver enzymes (ALP, ALT, AST) or total bilirubin > 1.5 upper limit of normal (ULN)
  8. Serum creatinine > 2 mg/dl
  9. Recent infection (within 30 days)
  10. Receiving immunosuppressive medication or prednisone > 10 mg/day (or equivalent)
  11. Pregnant or breastfeeding women and those of childbearing potential who are not practicing a reliable form of contraception.
  12. 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.
  13. 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
  14. 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

Information from the National Library of Medicine

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): NCT03198468


Contacts
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Contact: Pam Ninneman 4252811864 pninneman@uptakemedical.com
Contact: Julie Arneson 2533348543 jarneson@uptakemedical.com

Locations
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Australia, New South Wales
Macquarie University Hospital Not yet recruiting
Sydney, New South Wales, Australia, 2109
Contact: Radhika Butala    +61 2 9812 3561    radhika@butala@mq.edu.au   
Principal Investigator: Daniel A Ing, MD, PhD         
Australia, Victoria
The Royal Melbourne Hospital Recruiting
Melbourne, Victoria, Australia, 3050
Contact: Casey McLeod    +61 437 440 251    casey.mcleod@mh.org.au   
Principal Investigator: Daniel Steinfort, MD, PhD         
Sponsors and Collaborators
Uptake Medical Technology, Inc.

Additional Information:
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Responsible Party: Uptake Medical Technology, Inc.
ClinicalTrials.gov Identifier: NCT03198468     History of Changes
Other Study ID Numbers: CSP-2313
First Posted: June 26, 2017    Key Record Dates
Last Update Posted: November 4, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Uptake Medical Technology, Inc.:
Non Small Cell Lung Cancer
Metastatic Lung Cancer
Lung Cancer
Vapor Ablation
BTVA
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms