Percutaneous Image Guided Video-Assisted Thoracic Surgery (VATS) Resection of Lung Lesions
1 other identifier
interventional
25
1 country
1
Brief Summary
This is a phase II protocol to determine the safety and feasibility of Intraoperative CT fluoroscopy guidance for lung resection for small nodules.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2 lung-cancer
Started Apr 2013
Typical duration for phase_2 lung-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2013
CompletedFirst Submitted
Initial submission to the registry
May 2, 2013
CompletedFirst Posted
Study publicly available on registry
May 6, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2017
CompletedResults Posted
Study results publicly available
April 29, 2019
CompletedNovember 18, 2025
November 1, 2025
4.4 years
May 2, 2013
January 4, 2017
November 12, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0
The patient will be monitored while in the hospital by their thoracic surgical team as well as by two research nurses named Lauren Donahue, RN and Karen Magsipoc, NP. The research nurses will document any perioperative complications and mortality that arise during the patient's stay in the hospital.
30 days
Secondary Outcomes (1)
Patients Underwent a Successful Resection
30 days
Study Arms (1)
CT Marking and VATS lung wedge resection
EXPERIMENTALEach patient with a lung nodule meeting criteria will undergo marking with fiducials followed at the same time by Video-Assisted Thoracic Surgery (VATS) lung wedge resection under CT fluoroscopy.
Interventions
Eligibility Criteria
You may qualify if:
- peripheral lung nodules \< 3cm in size
- Surgical candidate
You may not qualify if:
- Non surgical candidate
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Brigham and Women's Hospitallead
- Siemens Medical Solutions USA - CSGcollaborator
Study Sites (1)
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
Related Publications (1)
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.
PMID: 26031893BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Raphael Bueno
- Organization
- Brigham and Women's Hospital
Study Officials
- PRINCIPAL INVESTIGATOR
Raphael Bueno, M.D.
Brigham and Women's Hospital
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Chief of Thoracic Surgery; Professor of Surgery
Study Record Dates
First Submitted
May 2, 2013
First Posted
May 6, 2013
Study Start
April 1, 2013
Primary Completion
September 1, 2017
Study Completion
September 1, 2017
Last Updated
November 18, 2025
Results First Posted
April 29, 2019
Record last verified: 2025-11