Status:
RECRUITING
Avecure Flexible Microwave Ablation Probe For Lung Nodules
Lead Sponsor:
Beth Israel Deaconess Medical Center
Collaborating Sponsors:
MedWaves, Inc
Dana-Farber Cancer Institute
Conditions:
Stage I - II Primary Lung Cancer
Stage I Lung Cancer
Eligibility:
All Genders
22+ years
Phase:
NA
Brief 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 ablat...
Detailed 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 broncho...
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.
Key Trial Info
Start Date :
June 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2027
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT05281237
Start Date
June 1 2022
End Date
June 30 2027
Last Update
February 5 2025
Active Locations (1)
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1
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02115