Image Guided VATS Resection vs. VATS Resection of Lung Lesions
Brigham and Women's Hospital
Summary
To evaluate workflow and outcomes of iVATS and standard VATS for small pulmonary nodules. The outcomes of the patients will be evaluated separately as there will be no direct comparison of the two arms.
Description
This is a prospective phase II clinical study to evaluate iVATS and standard VATS for small pulmonary nodules. We have successfully completed and published a phase I/pilot study with 25 patients demonstrating safety and optimal procedural workflow for combining image-guidance with VATS. This phase II clinical study will further expand upon the safety and feasibility of this procedure. Additionally, this data will be used to design a phase III comparison study between iVATS and standard VATS.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Subject must be 18 years and older * Subject must be deemed a candidate for the iVATS surgery, by their treating Thoracic Surgeon * Subject must have nodules/GGO or other abnormal opacity that can be accurately measured in at least one dimension with longest diameter ≤ 20 mm or 2cm * Subject's lesions that are located in the outer half portion of the lung/lobe. * Subjects must be evaluated at BWH and/or DFCI Thoracic Surgery outpatient clinics Exclusion Criteria: * If participant is a pregnant woman or breast feeding they will not be eligible. * If treating thoracic su…
Interventions
- DeviceImage guided Video-Assisted Thoracic Surgery (VATS) resection
Image guided placement of a fiducial consisting of a needle directed placement of a T-Bar next to the target lesion in order to lead the surgeon to the lung region to be removed
- ProcedureVideo-Assisted Thoracic Surgery
Standard of Care Video-Assisted Thoracic Surgery (VATS) resection
Location
- Brigham and Women's HospitalBoston, Massachusetts