Lung Cancer Clinical Trial

Image Guided VATS vs. VATS Resection

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.

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Full 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.

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Eligibility Criteria

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.

Study is for people with:

Lung Cancer

Estimated Enrollment:

200

Study ID:

NCT03623958

Recruitment Status:

Recruiting

Sponsor:

Brigham and Women's Hospital

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There is 1 Location for this study

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Brigham and Women's Hospital
Boston Massachusetts, 02115, United States More Info
Raphael Bueno, MD
Contact
617-732-5004
[email protected]
Julianne Barlow
Contact
617-525-8704
[email protected]

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Study is for people with:

Lung Cancer

Estimated Enrollment:

200

Study ID:

NCT03623958

Recruitment Status:

Recruiting

Sponsor:


Brigham and Women's Hospital

How clear is this clinincal trial information?

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