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Feasibility Study of the RF Ablation Catheter to Ablate Lung Tumors

This study is not yet open for participant recruitment.
Verified September 2017 by Broncus Medical Inc
Sponsor:
ClinicalTrials.gov Identifier:
NCT03272971
First Posted: September 6, 2017
Last Update Posted: September 6, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
Uptake Medical Technology, Inc.
Information provided by (Responsible Party):
Broncus Medical Inc
  Purpose
The feasibility of a RF ablation catheter to bronchoscopically ablate lung tumors, will be evaluated in patients already scheduled for surgical resection.

Condition Intervention
Lung Cancer Lung Cancer Metastatic Lung Cancer, Non-small Cell Device: Radio-frequency Ablation

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Official Title: Feasibility Study of the RF Ablation Catheter to Ablate Lung Tumors

Resource links provided by NLM:


Further study details as provided by Broncus Medical Inc:

Primary Outcome Measures:
  • RFA relate AEs/SAEs [ Time Frame: Day 0 ]
    The incidence of reported adverse events and serious adverse events related to the RFA procedure

  • Feasibility - Ablated Tissue [ Time Frame: Day 0 ]
    Semi-quantitative scoring of necrotic tissue assessed by histology

  • Feasibility - Delivery of Ablation [ Time Frame: Day 0 ]
    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.


Estimated Enrollment: 10
Anticipated Study Start Date: September 27, 2017
Estimated Study Completion Date: March 5, 2018
Estimated Primary Completion Date: November 30, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Radio-frequency Ablation
Single-arm study where subjects receive radio-frequency ablation prior to a scheduled, surgical resection.
Device: Radio-frequency Ablation
The intervention consists of a bronchoscopic approach to ablate lung tumors with radiofrequency.

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
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): NCT03272971


Contacts
Contact: Mia Park 206-926-7416 mpark@uptakemedical.com

Locations
China, Guangdong
The First Affiliated Hospital of Guangzhou Medical University Not yet recruiting
Guangzhou, Guangdong, China
Contact: Shiyue Li, M.D.         
Principal Investigator: Shiyue Li, M.D.         
Sponsors and Collaborators
Broncus Medical Inc
Uptake Medical Technology, Inc.
  More Information

Responsible Party: Broncus Medical Inc
ClinicalTrials.gov Identifier: NCT03272971     History of Changes
Other Study ID Numbers: Protocol 45
First Submitted: August 31, 2017
First Posted: September 6, 2017
Last Update Posted: September 6, 2017
Last Verified: September 2017

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
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Broncus Medical Inc:
lung cancer
radiofrequency ablation
bronchoscopy
NSCLC

Additional relevant MeSH terms:
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