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NCT03623958NARecruiting

Image Guided VATS vs. VATS Resection

Brigham and Women's Hospital

Start Date

9/11/2018

Completion Date

7/31/2027

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.

Detailed 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 Criteria

Age Range: 18 years to No maximum

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.

Interventions

DEVICE

Image guided Video-Assisted Thoracic Surgery (VATS) resection

PROCEDURE

Video-Assisted Thoracic Surgery

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Conditions

Lung Cancer

Locations

Brigham and Women's Hospital

Boston, Massachusetts 02115

United States