Image-guided VATS versus standard VATS to remove small lung nodules.
Official title: Image Guided VATS Resection vs. VATS Resection of Lung Lesions
Run by Brigham and Women's Hospital · NCT03623958 · Data updated 2026-11-12
We will test image-guided VATS and standard VATS to see how they perform for adults with small peripheral lung nodules (≤2 cm).
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 200 (estimated) |
| Sponsor | Brigham and Women's Hospital Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Status | Recruiting |
| Started | September 11, 2018 |
| Main results expected | July 31, 2027 |
| Study ends | July 31, 2027 |
| Registry record updated | November 13, 2025 |
| Trial ID | NCT03623958 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (≥18) who are judged surgical candidates for VATS, have a peripheral nodule or ground-glass opacity ≤20 mm located in the outer half of the lung, and are evaluated at the participating thoracic surgery clinics.
✕Probably not a fit
Pregnant or breastfeeding individuals, those deemed not eligible for surgery by their thoracic surgeon, or patients with lesions larger than 2 cm or located deep in the lung are unlikely to benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This prospective phase II study enrolls adults undergoing either image-guided video-assisted thoracoscopic surgery (iVATS) or standard VATS for small pulmonary nodules. Each arm's workflow and patient outcomes will be recorded and analyzed separately rather than directly compared. The protocol expands on a published phase I pilot of 25 patients that demonstrated safety and a feasible procedural workflow for combining image guidance with VATS. Collected data will inform safety and feasibility conclusions and help design a future randomized phase III comparison.
Why it matters
Potential benefit: If successful, image-guided VATS could allow surgeons to locate and remove small lung nodules more precisely, potentially reducing operative time and complications.
How similar studies have gone: A prior phase I/pilot of 25 patients at the same center showed safety and workable workflow, but randomized comparisons with standard VATS have not yet been done.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
-
Brigham and Women's Hospital
Boston, Massachusetts, United States Recruiting
Study contacts
- Principal investigator: Raphael Bueno, MD — Brigham and Women's Hospital
- Study coordinator: Julianne S Barlow
- Email: jbarlow1@bwh.harvard.edu
- Phone: 617-525-8704
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.