ANET Electrosurgery Applicator Pilot Evaluation Study

Olympus

Status: Terminated

Conditions: Lung Cancer Metastatic; Lung Cancer

Treatments: Device: RF Ablation

Study type: Interventional

Funder types: Industry

Identifiers

NCT03400748

15

Details and patient eligibility

About

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

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.

Enrollment: 6 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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6 participants in 1 patient group

RF Ablation

Experimental group

Description:

Single-arm study where subjects receive RF ablation prior to a scheduled surgical resection.

Treatment:

Device: RF Ablation