Avecure Flexible Microwave Ablation Probe For Lung Nodules
Feasibility and Efficacy of the AveCure Flexible Microwave Ablation Probe for Peripheral Lung Nodule
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 22 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Time periods mentioned: 30 days
- Procedures mentioned: CT scans
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "The names of the study intervention involved in this study is: * Cone Beam Computed Tomography (CBCT)-guided electromagnetic navigational bronchoscopy (ENB) microwave ablation (MWA) * A rapid on-site evaluation (ROSE) will be performed before the MWA to confirm that the lesion is malignant, this can lead to longer procedure time and time under anesthesia."
- "The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits. * Participants will receive the study intervention and will be followed for 30 days. * It is expected that about 10 people will take part in this research study."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
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)
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Official eligibility criteria
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.
Study sites (1)
MA
- Beth Israel Deaconess Medical Center · Boston, MA 02115Adnan Majid, MD · Sub-investigatorMihir S Parikh, MD · Sub-investigatorBeattie Jason, MD · Principal investigatorMore trials in Boston