Status:
TERMINATED
Feasibility Study of the RF Ablation Catheter to Ablate Lung Tumors
Lead Sponsor:
Broncus Medical Inc
Collaborating Sponsors:
Uptake Medical Technology, Inc.
Conditions:
Lung Cancer
Lung Cancer Metastatic
Eligibility:
All Genders
21-75 years
Phase:
NA
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) ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 5 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 30 2019
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT03272971
Start Date
December 5 2017
End Date
January 30 2019
Last Update
November 1 2019
Active Locations (1)
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1
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China