Lung Cancer Clinical Trial
Official title:
Feasibility Study of the RF Ablation Catheter to Ablate Lung Tumors
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.
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