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RecruitingInterventional

Image Guided VATS Resection vs. VATS Resection of Lung Lesions

NCT ID: NCT03623958Sponsor: Brigham and Women's HospitalLast updated: 2025-11-13

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.

Arms & interventions

  • DeviceImage 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

  • ProcedureVideo-Assisted Thoracic Surgery

    Standard of Care Video-Assisted Thoracic Surgery (VATS) resection

Outcome measures

Primary

  • Operating Room Time

    The time (in min.) from incision to close

    Time frame: 3 years to complete

Secondary

  • Time to T-bar placement

    Time frame: 3 years

  • Time for induction to incision

    Time frame: 3 years

  • Hospital Length of Stay

    Time frame: 3 years

  • Radiation Exposure

    Time frame: 3 years

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No
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 locations (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115

Recruiting
Raphael Bueno, MD · Contact
617-732-5004rbueno@bwh.harvard.edu
Julianne Barlow · Contact
617-525-8704jbarlow1@bwh.harvard.edu

References

  • 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.(PubMed)