RecruitingNot ApplicableNCT05281237

Avecure Flexible Microwave Ablation Probe For Lung Nodules

Feasibility and Efficacy of the AveCure Flexible Microwave Ablation Probe for Peripheral Lung Nodule


Sponsor

Beth Israel Deaconess Medical Center

Enrollment

10 participants

Start Date

Jun 1, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

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)


Eligibility

Min Age: 22 Years

Inclusion Criteria5

  • 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 Criteria10

  • 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.

Interventions

DEVICEAveCure 16 Gauge Flexible Microwave Ablation Probe

Microwave ablation of the solitary pulmonary nodule will be performed through a bronchoscopic approach using the AveCure Flexible Microwave Ablation Probe before surgery


Locations(1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

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NCT05281237


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