Lung Cancer Clinical Trial

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ANET Electrosurgery Applicator Pilot Evaluation Study

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Summary

Evaluate the preliminary safety and performance of the Electrosurgery Applicator (ANET device) during and after bronchoscopic ablation of a target pulmonary nodule/tumor.

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Full Description

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.

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Eligibility Criteria

Inclusion Criteria:

Subject with Stage I or Stage II primary lung cancer or metastatic lung tumor
Pathological proof of target nodule/tumor type and malignancy
Target nodule/tumor which can be accessed via EBUS bronchoscopy
Resection/surgical candidate
Participants must be at least 18 years old and able to provide consent

Exclusion criteria:

Subjects in whom flexible bronchoscopy is contraindicated
Target nodule < 1.0 cm
Prior radiation or neo adjuvant chemotherapy of the target nodule/tumor
Any comorbidity that the investigator feels would interfere with the safety of the subject or the evaluation of study objectives
Pacemaker, implantable cardioverter, or other electronic implantable device

Study is for people with:

Lung Cancer

Estimated Enrollment:

6

Study ID:

NCT03400748

Recruitment Status:

Terminated

Sponsor:

Spiration, Inc.

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There are 4 Locations for this study

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Beth Israel Deaconess Medical Center
Boston Massachusetts, 02215, United States
Duke University Medical Center
Durham North Carolina, 27710, United States
UT MD Anderson Cancer Center
Houston Texas, 77030, United States
Toronto General Hospital
Toronto Ontario, M5G 2, Canada

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Estimated Enrollment:

6

Study ID:

NCT03400748

Recruitment Status:

Terminated

Sponsor:


Spiration, Inc.

How clear is this clinincal trial information?

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