Image Guided VATS vs. VATS Resection

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Brigham and Women's Hospital
Study ID
NCT03623958
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Image guided Video-Assisted Thoracic Surgery (VATS) resection — DEVICE
    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 — PROCEDURE
    Standard of Care Video-Assisted Thoracic Surgery (VATS) resection

Study Details

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.

Key Dates

Start date
Sep 11, 2018
Status verified
Nov 2025
Primary completion
Jul 31, 2027
Completion
Jul 31, 2027

Study Design

Enrollment
200 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: iVATS resection
    Image guided Video-assisted thoracoscopic surgery (VATS) in either one of two hybrid operating rooms and Fine Needle Aspiration (FNA) under fluoroscopy.
  • Active Comparator: Standard VATS resection
    Standard video-assisted thoracoscopic surgery (VATS) in operating room and Fine Needle Aspiration (FNA) in pathology frozen section room.

Primary Outcome Measure

Operating Room Time [ Time Frame: 3 years to complete ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Brigham and Women's HospitalBostonMassachusetts02115
Raphael Bueno, MD
[email protected]
617-732-5004
Julianne Barlow
[email protected]
617-525-8704

Find similar trials in Boston, MA

By condition
Lung cancer
By specialty
OncologyLung oncologyLung disease
By research site
Brigham and Women's Hospital· Boston, MA

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