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AveCure Flexible Microwave Ablation Probe for Early-Stage Lung Cancer

This study is testing a new way to treat early-stage lung cancer using the AveCure Flexible Microwave Ablation Probe. This probe uses microwave energy to destroy cancerous lung nodules up to 3 cm (about 1.2 inches) in size. The treatment is done through a bronchoscope (a thin tube inserted into the airways). Doctors will check how well the treatment works by looking at the rate of planned ablations and changes in the tumor tissue after 4 weeks. You might be able to join if you have Stage I or II primary lung cancer with a solitary nodule up to 3 cm that can be reached by a bronchoscope. This is a pilot study, meaning it's the first time this approach is being studied for this specific use. The FDA has approved this intervention as a treatment option for this disease.

Study design
This is a single-arm study, meaning all participants receive the same treatment. About 10 people are expected to take part in this pilot study.
What's involved
You would undergo screening, receive the AveCure Flexible Microwave Ablation Probe treatment, and have follow-up visits for 30 days. A rapid on-site evaluation (ROSE) will be performed before the treatment, which may lead to a longer procedure time.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 30 days after receiving the study intervention.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05281237

Avecure Flexible Microwave Ablation Probe For Lung Nodules

Recruiting
NAAges 22+InterventionalTreatment
Beth Israel Deaconess Medical Center
~10 participants
Updated 2026-04-08 on ClinicalTrials.gov
What's tested:AveCure 16 Gauge Flexible Microwave Ablation Probe

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Rate of Planned Ablations.
Measured over Day 1
+1 more outcome measured

Conditions

Stage I - II Primary Lung Cancer
Stage I Lung Cancer
Stage II Lung Cancer
Lung Cancer Stage I
Lung Cancer Stage II
Lung Cancer

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Lung Carcinoma

Where it's being run

1 sites across 1 states
Massachusetts1

Study leadership

  • Jason Beattie, MD · PRINCIPAL_INVESTIGATOR · Beth Israel Deaconess Medical Center

Who to contact

Jason Beattie, MD
[email protected]
(617) 632- 8252
Email the study team

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Rate of Planned Ablations.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.

  • Pathological changes in the tumor tissue.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.