ANET Electrosurgery Applicator Pilot Evaluation Study
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|ClinicalTrials.gov Identifier: NCT03400748|
Recruitment Status : Terminated (business reason)
First Posted : January 17, 2018
Results First Posted : September 27, 2021
Last Update Posted : September 27, 2021
|Condition or disease||Intervention/treatment||Phase|
|Lung Cancer Lung Cancer Metastatic||Device: RF Ablation||Not Applicable|
This study is a prospective, single arm, single center study that will evaluate the effectiveness of the ANET Electrosurgery Applicator in up to 10 subjects.
Subjects who consent to participate in this study will have a lung tumor that is scheduled to be removed surgically as part of their normal treatment. During the surgical procedure, just prior to resection the subject's tumor will be treated with the ANET device. The ANET device uses a bronchoscope to reach the tumor. Ultrasound on the bronchoscope, CT, and X-rays are used to make sure the ANET device is in the tumor. Once in the tumor, the ANET device uses radio-frequency (RF) ablation to treat the tumor. After standard surgical resection the tumor and surrounding tissue is evaluated to characterize the effect of the ANET.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||6 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Device Feasibility|
|Official Title:||ANET Electrosurgery Applicator Pilot Evaluation Study|
|Actual Study Start Date :||April 23, 2018|
|Actual Primary Completion Date :||November 18, 2020|
|Actual Study Completion Date :||November 18, 2020|
Experimental: RF Ablation
Single-arm study where subjects receive RF ablation prior to a scheduled surgical resection.
Device: RF Ablation
The intervention consists of a bronchoscopic approach to ablate lung tumors with radio-frequency energy.
- ANET Related Peri-procedural Adverse Events [ Time Frame: Day 0 ]The incidence of reported adverse events and serious adverse events related to the ANET device or procedure
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03400748
|United States, Massachusetts|
|Beth Israel Deaconess Medical Center|
|Boston, Massachusetts, United States, 02215|
|United States, North Carolina|
|Duke University Medical Center|
|Durham, North Carolina, United States, 27710|
|United States, Texas|
|UT MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Toronto General Hospital|
|Toronto, Ontario, Canada, M5G 2C4|