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Feasibility Study of the RF Ablation Catheter to Ablate Lung Tumors

Primary Purpose

Lung Cancer, Lung Cancer Metastatic, Lung Cancer, Non-small Cell

Status
Terminated
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Radio-frequency Ablation
Sponsored by
Broncus Medical Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional device feasibility trial for Lung Cancer focused on measuring lung cancer, radiofrequency ablation, bronchoscopy, NSCLC

Eligibility Criteria

21 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Proven NSCLC or pulmonary metastases from extra-thoracic primary tumor
  • Must be eligible for curative lung resection (lobectomy)
  • Tumor/lesion size will be a minimum of 10mm along the minor diameter
  • Willing to participate in all aspects of study protocol for duration of the study
  • Able to understand study requirements
  • Signs informed consent form

Exclusion Criteria:

  • Any contraindication to bronchoscopy, for example:

    • Untreatable life-threatening arrhythmias.
    • Inability to adequately oxygenate the patient during the procedure.
    • Acute respiratory failure with hypercapnia (unless the patient is intubated and ventilated).
    • Recent myocardial infarction.
    • Previously diagnosed high-grade tracheal obstruction.
    • Uncorrectable coagulopathy
  • Known coagulopathy
  • Platelet dysfunction or platelet count <100 x 10^3 cells/mm3
  • History of major bleeding with bronchoscopy
  • Suspected pulmonary hypertension: additional testing required, such as ECG
  • Moderate-to-severe pulmonary fibrosis
  • Severe emphysema (GOLD III/IV) or chronic obstructive pulmonary disease (COPD):

additional testing and PI consent is required

  • Bullae >5cm located within the same lobe of target tumor/lesion
  • Any other severe or life-threatening comorbidity that could increase the risk associated with bronchoscopic RFA
  • Ongoing systemic infection
  • Contraindications to general anesthesia
  • Inability to stop anticoagulants or antiplatelet agents prior to procedure as dictated by the protocol
  • Prior thoracic surgery on the same side of the lung as the targeted tumor/lesion
  • Breastfeeding women or females of childbearing potential with a positive pregnancy test prior to the procedure or the intent to become pregnant during the study
  • Life expectancy of less than one year.

Sites / Locations

  • The First Affiliated Hospital of Guangzhou Medical University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Radio-frequency Ablation

Arm Description

Single-arm study where subjects receive radio-frequency ablation prior to a scheduled, surgical resection.

Outcomes

Primary Outcome Measures

RFA relate AEs/SAEs
The incidence of reported adverse events and serious adverse events related to the RFA procedure
Feasibility - Ablated Tissue
Semi-quantitative scoring of necrotic tissue assessed by histology
Feasibility - Delivery of Ablation
Treatment meets the required procedural steps/requirements per the Operator's Manual and treatment is delivered to the target tumor per the individual patient navigation plan.

Secondary Outcome Measures

Full Information

First Posted
August 31, 2017
Last Updated
October 30, 2019
Sponsor
Broncus Medical Inc
Collaborators
Uptake Medical Technology, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03272971
Brief Title
Feasibility Study of the RF Ablation Catheter to Ablate Lung Tumors
Official Title
Feasibility Study of the RF Ablation Catheter to Ablate Lung Tumors
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Terminated
Why Stopped
Lack of enrollment
Study Start Date
December 5, 2017 (Actual)
Primary Completion Date
January 30, 2019 (Actual)
Study Completion Date
January 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Broncus Medical Inc
Collaborators
Uptake Medical Technology, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
The feasibility of a RF ablation catheter to bronchoscopically ablate lung tumors, will be evaluated in patients already scheduled for surgical resection.
Detailed Description
This study is a prospective, single-arm, single-center, pilot study of bronchoscopic Radio-Frequency Ablation (RFA) treatment of target lung lesions, prior to surgical tumor resection. Up to ten (10) subjects will be treated at the investigational site. 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 RFA treatment. Prior to RFA, high-resolution computed tomography (HRCT) scans will be used to characterize the lesion and determine the access pathways for ablation. At the time of the RFA procedure, a point-of-entry, along a bronchial wall, is created under an image-guided navigation system. The RFA catheter is advanced down the access path until it reaches the tumor and RF is administered at the prescribed dose. Upon completion of the RFA treatment, the subject is immediately prepared for surgical resection in accordance with their lung cancer standard of care. There are no follow-up visits as part of this study, the subject is excited following surgical resection. The resected tissue will undergo pathological evaluation for tissue viability.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer, Lung Cancer Metastatic, Lung Cancer, Non-small Cell
Keywords
lung cancer, radiofrequency ablation, bronchoscopy, NSCLC

7. Study Design

Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
3 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Radio-frequency Ablation
Arm Type
Experimental
Arm Description
Single-arm study where subjects receive radio-frequency ablation prior to a scheduled, surgical resection.
Intervention Type
Device
Intervention Name(s)
Radio-frequency Ablation
Intervention Description
The intervention consists of a bronchoscopic approach to ablate lung tumors with radiofrequency.
Primary Outcome Measure Information:
Title
RFA relate AEs/SAEs
Description
The incidence of reported adverse events and serious adverse events related to the RFA procedure
Time Frame
Day 0
Title
Feasibility - Ablated Tissue
Description
Semi-quantitative scoring of necrotic tissue assessed by histology
Time Frame
Day 0
Title
Feasibility - Delivery of Ablation
Description
Treatment meets the required procedural steps/requirements per the Operator's Manual and treatment is delivered to the target tumor per the individual patient navigation plan.
Time Frame
Day 0

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Proven NSCLC or pulmonary metastases from extra-thoracic primary tumor Must be eligible for curative lung resection (lobectomy) Tumor/lesion size will be a minimum of 10mm along the minor diameter Willing to participate in all aspects of study protocol for duration of the study Able to understand study requirements Signs informed consent form Exclusion Criteria: Any contraindication to bronchoscopy, for example: Untreatable life-threatening arrhythmias. Inability to adequately oxygenate the patient during the procedure. Acute respiratory failure with hypercapnia (unless the patient is intubated and ventilated). Recent myocardial infarction. Previously diagnosed high-grade tracheal obstruction. Uncorrectable coagulopathy Known coagulopathy Platelet dysfunction or platelet count <100 x 10^3 cells/mm3 History of major bleeding with bronchoscopy Suspected pulmonary hypertension: additional testing required, such as ECG Moderate-to-severe pulmonary fibrosis Severe emphysema (GOLD III/IV) or chronic obstructive pulmonary disease (COPD): additional testing and PI consent is required Bullae >5cm located within the same lobe of target tumor/lesion Any other severe or life-threatening comorbidity that could increase the risk associated with bronchoscopic RFA Ongoing systemic infection Contraindications to general anesthesia Inability to stop anticoagulants or antiplatelet agents prior to procedure as dictated by the protocol Prior thoracic surgery on the same side of the lung as the targeted tumor/lesion Breastfeeding women or females of childbearing potential with a positive pregnancy test prior to the procedure or the intent to become pregnant during the study Life expectancy of less than one year.
Facility Information:
Facility Name
The First Affiliated Hospital of Guangzhou Medical University
City
Guangzhou
State/Province
Guangdong
Country
China

12. IPD Sharing Statement

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Feasibility Study of the RF Ablation Catheter to Ablate Lung Tumors

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