Avecure Flexible Microwave Ablation Probe For Lung Nodules
Recruiting · NCT05281237 · Interventional (participants receive a specific treatment) · Lead sponsor: Beth Israel Deaconess Medical Center
View the official record on ClinicalTrials.gov →Interventions studied
AveCure 16 Gauge Flexible Microwave Ablation Probe
What this trial is about
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)
Who can take part
Age range
22 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
1 location listed across 1 US state.
- Beth Israel Deaconess Medical Center - Boston, Massachusetts, United States