Feasibility Study of the RF Ablation Catheter to Ablate Lung Tumors
|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.|
|ClinicalTrials.gov Identifier: NCT03272971|
Recruitment Status : Recruiting
First Posted : September 6, 2017
Last Update Posted : January 30, 2018
|Condition or disease||Intervention/treatment|
|Lung Cancer Lung Cancer Metastatic Lung Cancer, Non-small Cell||Device: Radio-frequency Ablation|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|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|
|Actual Study Start Date :||December 5, 2017|
|Estimated Primary Completion Date :||June 30, 2018|
|Estimated Study Completion Date :||July 5, 2018|
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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03272971
|Contact: Mia Parkemail@example.com|
|The First Affiliated Hospital of Guangzhou Medical University||Recruiting|
|Guangzhou, Guangdong, China|
|Contact: Shiyue Li, M.D.|
|Principal Investigator: Shiyue Li, M.D.|