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.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
200
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
Standard of Care Video-Assisted Thoracic Surgery (VATS) resection
Brigham and Women's Hospital
Boston, Massachusetts, United States
RECRUITINGOperating Room Time
The time (in min.) from incision to close
Time frame: 3 years to complete
Time to T-bar placement
The time from patient ready for surgery to placement of t-bar
Time frame: 3 years
Time for induction to incision
Time (in min) from induction to incision made
Time frame: 3 years
Hospital Length of Stay
Length of hospital stay (in days) in both arms
Time frame: 3 years
Radiation Exposure
The radiation exposure (mSV) in the iVATS arm
Time frame: 3 years
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