ANET Electrosurgery Applicator Pilot Evaluation Study

Olympus Corporation of the Americas6 enrolled

Overview

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

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

Allocation

Purpose

DEVICE_FEASIBILITY

Masking

NONE

Enrollment

Conditions

Lung Cancer Lung Cancer Metastatic

Interventions

RF AblationDEVICE

The intervention consists of a bronchoscopic approach to ablate lung tumors with radio-frequency energy.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Subject with Stage I or Stage II primary lung cancer or metastatic lung tumor 2. Pathological proof of target nodule/tumor type and malignancy 3. Target nodule/tumor which can be accessed via EBUS bronchoscopy 4. Resection/surgical candidate 5. Participants must be at least 18 years old and able to provide consent Exclusion criteria: 1. Subjects in whom flexible bronchoscopy is contraindicated 2. Target nodule \< 1.0 cm 3. Prior radiation or neo adjuvant chemotherapy of the target nodule/tumor 4. Any comorbidity that the investigator feels would interfere with the safety of the subject or the evaluation of study objectives 5. Pacemaker, implantable cardioverter, or other electronic implantable device

Locations (4)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Duke University Medical Center

Durham, North Carolina, United States

UT MD Anderson Cancer Center

Houston, Texas, United States

Toronto General Hospital

Toronto, Ontario, Canada

Outcomes

Primary Outcomes

ANET Related Peri-procedural Adverse Events

The incidence of reported adverse events and serious adverse events related to the ANET device or procedure

Time frame: Day 0

Data from ClinicalTrials.gov

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