What this study is
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)
What's being tested
- AveCure 16 Gauge Flexible Microwave Ablation Probe
Intervention · DEVICE
Microwave ablation of the solitary pulmonary nodule will be performed through a bronchoscopic approach using the AveCure Flexible Microwave Ablation Probe before surgery
Study details
- Official title
- Feasibility and Efficacy of the AveCure Flexible Microwave Ablation Probe for Peripheral Lung Nodule
- Sponsor
- Beth Israel Deaconess Medical Center
- 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
- Enrolling
- 10 people
- Starts
- 2022-06-01
- Est. completion
- 2027-06-30
- Design
- Open-label, single group
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 22 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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
You can't join if
- 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.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openBeth Israel Deaconess Medical Center
Boston, Massachusetts, United States
- Adnan Majid, MD · Sub-investigator
- Mihir S Parikh, MD · Sub-investigator
- Beattie Jason, MD · Principal investigator
Recruiting
Study team
Sponsor
Beth Israel Deaconess Medical Center
Study ID 21-412
Principal investigator
Jason Beattie, MD
Beth Israel Deaconess Medical Center
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.