Trials / Recruiting
RecruitingNCT05281237
Avecure Flexible Microwave Ablation Probe For Lung Nodules
Feasibility and Efficacy of the AveCure Flexible Microwave Ablation Probe for Peripheral Lung Nodule
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 10 (estimated)
- Sponsor
- Beth Israel Deaconess Medical Center · Academic / Other
- Sex
- All
- Age
- 22 Years
- Healthy volunteers
- Not accepted
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 ablation (MWA)
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 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. This research study is a Pilot Study, which is the first-time investigators are examining this intervention using a bronchoscopic approach for microwave ablation of solitary pulmonary nodules. The U.S. Food and Drug Administration (FDA) has approved this intervention as a treatment option for this disease.
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
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | AveCure 16 Gauge Flexible Microwave Ablation Probe | Microwave ablation of the solitary pulmonary nodule will be performed through a bronchoscopic approach using the AveCure Flexible Microwave Ablation Probe before surgery |
Timeline
- Start date
- 2022-06-01
- Primary completion
- 2026-12-30
- Completion
- 2027-06-30
- First posted
- 2022-03-16
- Last updated
- 2026-04-08
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT05281237. Inclusion in this directory is not an endorsement.