Avecure Flexible Microwave Ablation Probe For Lung Nodules

Last updated: February 3, 2025
Sponsor: Beth Israel Deaconess Medical Center
Overall Status: Active - Recruiting

Phase

N/A

Condition

Lung Cancer

Lung Disease

Non-small Cell Lung Cancer

Treatment

AveCure 16 Gauge Flexible Microwave Ablation Probe

Clinical Study ID

NCT05281237
21-412
  • Ages > 22
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • Subject with Stage I - II primary lung cancer (Solitary nodules up to 3 cm) asdefined by previous pathology or ROSE.

  • Pathological proof of target nodule/tumor type and malignancy with specimenconsidered adequate per institutional laboratory standards

  • Target nodule/tumor which can be accessed via navigational bronchoscopy andconfirmed 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

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 thesubject 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.

Study Design

Total Participants: 10
Treatment Group(s): 1
Primary Treatment: AveCure 16 Gauge Flexible Microwave Ablation Probe
Phase:
Study Start date:
June 01, 2022
Estimated Completion Date:
June 30, 2027

Study 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.

Connect with a study center

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts 02115
    United States

    Active - Recruiting

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