Avecure Flexible Microwave Ablation Probe For Lung Nodules

Beth Israel Lahey Health

Status: Enrolling

Conditions: Lung Cancer Stage I; Stage I - II Primary Lung Cancer; Lung Cancer; Stage II Lung Cancer; Lung Cancer Stage II; Stage I Lung Cancer

Treatments: Device: AveCure 16 Gauge Flexible Microwave Ablation Probe

Study type: Interventional

Funder types: Other

Identifiers

NCT05281237

21-412

Details and patient eligibility

About

This research study to determine the effectiveness of the AveCure Flexible Microwave Ablation Probe to destroy cancerous lung nodules up to 3 c m in size.

This research study involves microwave ablation (MWA)

Full description

This will be a single arm, prospective cohort study.

The names of the study intervention involved in this study is:

• Cone Beam Computed Tomography (CBCT)-guided electromagnetic navigational bronchoscopy (ENB) microwave ablation (MWA)
• A rapid on-site evaluation (ROSE) will be performed before the MWA to confirm that the lesion is malignant, this can lead to longer procedure time and time under anesthesia.

The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits.

• Participants will receive the study intervention and will be followed for 30 days.
• It is expected that about 10 people will take part in this research study.

This research study is a Pilot Study, which is the first-time investigators are examining this intervention using a bronchoscopic approach for microwave ablation of solitary pulmonary nodules.

The U.S. Food and Drug Administration (FDA) has approved this intervention as a treatment option for this disease.

Enrollment: 10 estimated patients

Sex: All

Ages: 22+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subject with Stage I - II primary lung cancer (Solitary nodules up to 3 cm) as defined by previous pathology or ROSE.
• Pathological proof of target nodule/tumor type and malignancy with specimen considered adequate per institutional laboratory standards
• Target nodule/tumor which can be accessed via navigational bronchoscopy and confirmed location with cone beam CT scan intra-operatively
• Resection/surgical candidate (lobectomy or greater)
• Participants must be at least 22 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 another electronic implantable device
• Patient cannot tolerate bronchoscopy
• Patients with coagulopathy
• Patients in other therapeutic lung cancer studies
• Subject is pregnant or breastfeeding
• COVID-19 positive patient at the time of procedure.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

AVECURE FLEXIBLE MICROWAVE ABLATION PROBE FOR LUNG NODULES

Experimental group

Description:

The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits. * Ablation Procedure- MWA will be used to treat solitary pulmonary nodules up to 3cm. * CT scan will then be performed to evaluate the radiological changes 2 - 4 weeks after the ablation procedure. * Surgery will be performed to remove the lung nodule and the tissue will be evaluated by pathology.

Treatment:

Device: AveCure 16 Gauge Flexible Microwave Ablation Probe