RecruitingNot ApplicableNCT03623958
Image Guided VATS vs. VATS Resection
Image Guided VATS Resection vs. VATS Resection of Lung Lesions
Sponsor
Brigham and Women's Hospital
Enrollment
200 participants
Start Date
Sep 11, 2018
Study Type
INTERVENTIONAL
Conditions
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.
Eligibility
Min Age: 18 Years
Inclusion Criteria5
- 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 Criteria2
- If participant is a pregnant woman or breast feeding they will not be eligible.
- If treating thoracic surgeon deems the participant not eligible for the study.
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
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT03623958
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