An interventional study of Radio-frequency Ablation in Lung Cancer, Lung Cancer Metastatic and Lung Cancer, Non-small Cell, sponsored by Broncus Medical Inc. Terminated at 1 site in China. Open to participants aged 21 Years to 75 Years. Per ClinicalTrials.gov, last updated 2019-11-01.
Sponsored by Broncus Medical Inc · Not applicable, Interventional, and Device feasibility
The feasibility of a RF ablation catheter to bronchoscopically ablate lung tumors, will be evaluated in patients already scheduled for surgical resection.
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.
Exclusion Criteria:
Any contraindication to bronchoscopy, for example:
additional testing and PI consent is required
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.
RFA relate AEs/SAEs
The incidence of reported adverse events and serious adverse events related to the RFA procedure
Time frame: Day 0
Feasibility - Ablated Tissue
Semi-quantitative scoring of necrotic tissue assessed by histology
Time frame: Day 0
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.
Time frame: Day 0
This study is terminated, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.
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Broncus Medical Inc