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NCT Number: NCT05281237

Avecure Flexible Microwave Ablation Probe For Lung Nodules

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)

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Key information

Conditions

Stage I - II Primary Lung Cancer Lung Cancer Lung Cancer Stage I Lung Cancer Stage II Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Stage I Lung Cancer Stage II Lung Cancer Thoracic Neoplasms

Age range

22 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02115, United States

Location status: Recruiting

Location contact

Adnan Majid, MD

SUB_INVESTIGATOR

Beattie Jason, MD

PRINCIPAL_INVESTIGATOR

Mihir S Parikh, MD

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

AveCure 16 Gauge Flexible Microwave Ablation Probe

Device

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

Other names: Avecure

Primary outcomes

  1. Rate of Planned Ablations.

    Time frame: Day 1

    Feasibility of performing the procedure as planned in the enrolled patients. At least 9/10 of the planned ablations (90%) can be performed bronchoscopically according to the established protocol.

  2. Pathological changes in the tumor tissue.

    Time frame: 4 weeks

    Pathological evaluation of the acute thermal effect produced by the AveCUre 16G-FMAP on targeted malignant solitary lung nodules will be described. The % necrosis, % viable tumor, and % stroma/inflammation present in the targeted nodules after ablation will be described.

Secondary outcomes

  1. Histological changes in lung tissue outside the zone of predicted ablation.

    Time frame: 4 weeks

    A secondary analysis of the tissue surrounding the treated area will be performed. The % necrosis and of % stroma/inflammation will be described.

  2. Immune-histochemical changes in the tumor tissue.

    Time frame: 4 weeks

    Immune-histochemical evaluation including TTF-1, Napsin-A, p40, or other immune-histochemical assessments will be performed if needed on a per case basis.

Study contacts

Contact information is provided by the study sponsor or research team.

Jason Beattie, MD

CONTACT

[email protected]

(617) 632- 8252

Sponsors and collaborators

Lead sponsor

Beth Israel Deaconess Medical Center

Other

Collaborators

  • Dana-Farber Cancer Institute
  • MedWaves, Inc

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2026
Study completion
2027
First posted
Mar 16, 2022
Registry last updated
Apr 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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