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Vapor Ablation for Localized Cancer Lesions (VAPORIZED)

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ClinicalTrials.gov Identifier: NCT03514329
Recruitment Status : Not yet recruiting
First Posted : May 2, 2018
Last Update Posted : November 5, 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 the inclusion criteria and none of the exclusion criteria will receive vapor ablation treatment.

Patients will be followed for up to 12 months.


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 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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 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 Definitive Treatment Study
Estimated Study Start Date : April 1, 2020
Estimated Primary Completion Date : December 30, 2020
Estimated Study Completion Date : March 30, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Vapor Ablation
Patients treated with Bronchoscopic Thermal Vapor Ablation for lung cancer
Device: Bronchoscopic Thermal Vapor Ablation
Vapor (steam) is infused into the targeted region for 8 seconds at a precisely controlled flow rate and power.
Other Name: BTVA-C




Primary Outcome Measures :
  1. BTVA-C related AEs/SAEs [ Time Frame: up to 6 months post-ablation ]
    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: Day 0 ]
    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

  3. Local Control Evaluation per RECIST [ Time Frame: Month 1, 3, 6, and 12 ]
    Evaluation in the change in response to vapor ablation based on the RECIST 1.1 protocol



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. Patient has been recommended for ablation or recommended for an alternative to surgery
  3. Non-small cell lung cancer tumor(s) ≤ 2cm (T1aN0, T1bN0) OR Metastatic lung tumor(s) ≤ 2cm
  4. Microscopic proof of malignancy obtained
  5. Location of tumor:

    1. In periphery of lung (outermost 1/3)
    2. Maximum of three vapor ablation applications would target entire margin according to the vapor ablation plan
  6. Signed patient informed consent

Exclusion Criteria:

  1. Centralized tumor (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) <20% predicted, diffusing capacity of the lung for carbon monoxide (DLCO)<20% predicted
  5. Requirement for supplemental oxygen (includes at rest or during 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. Currently receiving immunosuppressive medication or prednisone > 10 mg/day (or equivalent)
  11. Pre-existing implants within the airways that impede navigation to the target lesion
  12. Pregnant or breastfeeding women and those of childbearing potential who are not practicing a reliable form of contraception.
  13. 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.
  14. 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
  15. 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): NCT03514329


Contacts
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Contact: Pam Ninneman 425-281-1864 pninneman@uptakemedical.com
Contact: Julie Arneson 253-334-8543 jarneson@uptakemedical.com

Locations
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Austria
Otto-Wagner Hospital Not yet recruiting
Vienna, Austria
Contact: Marina Duller       blvr.koordinator@gmail.com   
Principal Investigator: Arschang Valipour, MD         
Italy
Azienda Ospedaliero - Universitaria Recruiting
Ancona, Italy, I-60020
Contact: Martina Bonifazi, MD       martinabonifazi@libero.it   
Principal Investigator: Stefano Gasparini, MD         
Sponsors and Collaborators
Uptake Medical Technology, Inc.

Additional Information:
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Responsible Party: Uptake Medical Technology, Inc.
ClinicalTrials.gov Identifier: NCT03514329     History of Changes
Other Study ID Numbers: CSP-2315
First Posted: May 2, 2018    Key Record Dates
Last Update Posted: November 5, 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: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
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