Safety and feasibility of bronchoscopic microwave ablation technology for peripheral lung cancer: a multi-center, prospective, single-arm study protocol.
Jason Beattie, Ray Parrish, Laith Ayasa...
https://pubmed.ncbi.nlm.nih.gov/41137055Actively Recruiting
Phase Not Applicable
Age: 22Years +
All Genders
ID05281237
Feasibility and Efficacy of the AveCure Flexible Microwave Ablation Probe for Peripheral Lung Nodules
Led by Beth Israel Deaconess Medical Center · Updated on 2026-04-08
10
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
Sponsors
B
Beth Israel Deaconess Medical Center
Lead Sponsor
M
MedWaves, Inc
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness of the AveCure Flexible Microwave Ablation Probe for treating cancerous lung nodules up to 3 cm in size in people with Stage I or II primary lung cancer. This pilot study is the first to examine this microwave ablation method using a bronchoscopic approach. The intervention is FDA-approved for this disease and aims to assess its feasibility and efficacy. Participants will undergo the microwave ablation procedure via a bronchoscopic approach guided by Cone Beam Computed Tomography and electromagnetic navigational bronchoscopy. Before ablation, a rapid on-site evaluation will confirm the malignancy of the nodule. After the procedure, a CT scan will check for changes 2 to 4 weeks later, followed by surgery to remove the nodule for pathological examination. Participants will be followed for 30 days post-procedure. During the study, participants will have screening, treatment, and follow-up visits including imaging and tissue evaluations. Researchers will measure the rate of planned ablations and pathological changes in tumor tissue at 4 weeks. Secondary assessments include changes in lung tissue outside the ablation zone and immune-histochemical changes. The total participation time includes the procedure and at least 30 days of follow-up to monitor outcomes and safety.
CONDITIONS
Brief Title
Avecure Flexible Microwave Ablation Probe For Lung Nodules
Who Can Participate
Age: 22Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Have Stage I or II primary lung cancer with solitary nodules up to 3 cm confirmed by pathology or rapid on-site evaluation
- Have pathological proof of the target nodule and malignancy with adequate specimen
- Have a lung nodule accessible by navigational bronchoscopy and confirmed by cone beam CT scan during the procedure
- Be a candidate for lung surgery such as lobectomy or greater
- Be at least 22 years old and able to provide consent
You will not qualify if you...
- Cannot undergo flexible bronchoscopy
- Have lung nodules smaller than 1.0 cm
- Have had prior radiation or neoadjuvant chemotherapy to the target nodule
- Have any medical condition that would interfere with safety or study evaluation
- Have a pacemaker, implantable cardioverter, or other electronic implantable device
- Cannot tolerate bronchoscopy
- Have blood clotting disorders
- Are participating in other therapeutic lung cancer studies
- Are pregnant or breastfeeding
- Are COVID-19 positive at the time of procedure
AI-Screening
AI-Powered Screening
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1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Implementation
Duration - 1 day
Participants undergo microwave ablation of the solitary pulmonary nodule through a bronchoscopic approach using the AveCure Flexible Microwave Ablation Probe. A rapid on-site evaluation is performed before the ablation to confirm malignancy.
1 procedure visit (in-person)
Post-operative Follow-up
Duration - 4 weeks
Participants have a CT scan performed 2 to 4 weeks after the ablation procedure to evaluate radiological changes and later undergo surgery to remove the lung nodule for pathological evaluation.
1 follow-up visit and 1 surgery visit (in-person)
Trial Site Locations
Total: 1 location
1
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02115
Actively Recruiting
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Research Team
J
Jason Beattie, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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