Image Guided VATS vs. VATS Resection



Status:Not yet recruiting
Conditions:Lung Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:8/15/2018
Start Date:September 1, 2018
End Date:December 31, 2022
Contact:Julianne S Barlow
Email:jbarlow1@bwh.harvard.edu
Phone:617-525-8704

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Image Guided VATS Resection vs. VATS Resection of Lung Lesions

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.

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 surgeon deems the participant not eligible for the study.
We found this trial at
1
site
75 Francis street
Boston, Massachusetts 02115
(617) 732-5500
Phone: 617-732-5004
Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
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