Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
200 participants
INTERVENTIONAL
2018-09-11
2027-07-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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iVATS resection
Image guided Video-assisted thoracoscopic surgery (VATS) in either one of two hybrid operating rooms and Fine Needle Aspiration (FNA) under fluoroscopy.
Image 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
Standard VATS resection
Standard video-assisted thoracoscopic surgery (VATS) in operating room and Fine Needle Aspiration (FNA) in pathology frozen section room.
Video-Assisted Thoracic Surgery
Standard of Care Video-Assisted Thoracic Surgery (VATS) resection
Interventions
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Image 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
Video-Assisted Thoracic Surgery
Standard of Care Video-Assisted Thoracic Surgery (VATS) resection
Eligibility Criteria
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Inclusion Criteria
* 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 treating thoracic surgeon deems the participant not eligible for the study.
18 Years
ALL
No
Sponsors
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Brigham and Women's Hospital
OTHER
Responsible Party
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Raphael Bueno
Chief of Throacic Surgery
Principal Investigators
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Raphael Bueno, MD
Role: PRINCIPAL_INVESTIGATOR
Brigham and Women's Hospital
Locations
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Brigham and Women's Hospital
Boston, Massachusetts, United States
Countries
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Central Contacts
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Facility Contacts
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Raphael Bueno, MD
Role: primary
Julianne Barlow
Role: backup
References
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Gill RR, Zheng Y, Barlow JS, Jayender J, Girard EE, Hartigan PM, Chirieac LR, Belle-King CJ, Murray K, Sears C, Wee JO, Jaklitsch MT, Colson YL, Bueno R. Image-guided video assisted thoracoscopic surgery (iVATS) - phase I-II clinical trial. J Surg Oncol. 2015 Jul;112(1):18-25. doi: 10.1002/jso.23941. Epub 2015 May 28.
Other Identifiers
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2017P000291
Identifier Type: -
Identifier Source: org_study_id