NCT03272971

Feasibility Study of the RF Ablation Catheter to Ablate Lung Tumors

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: Broncus Medical Inc · Industry
• Sex: All
• Age: 21 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
DEVICE	Radio-frequency Ablation	The intervention consists of a bronchoscopic approach to ablate lung tumors with radiofrequency.

Timeline

• Start date: 2017-12-05
• Primary completion: 2019-01-30
• Completion: 2019-01-30
• First posted: 2017-09-06
• Last updated: 2019-11-01

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated device study