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Percutaneous Image Guided Video-Assisted Thoracic Surgery (VATS) Resection of Lung Lesions

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01847209
Recruitment Status : Completed
First Posted : May 6, 2013
Results First Posted : April 29, 2019
Last Update Posted : April 29, 2019
Sponsor:
Collaborator:
Siemens Medical Solutions USA - CSG
Information provided by (Responsible Party):
Raphael Bueno, Brigham and Women's Hospital

Tracking Information
First Submitted Date  ICMJE May 2, 2013
First Posted Date  ICMJE May 6, 2013
Results First Submitted Date  ICMJE January 4, 2017
Results First Posted Date  ICMJE April 29, 2019
Last Update Posted Date April 29, 2019
Study Start Date  ICMJE April 2013
Actual Primary Completion Date September 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 29, 2019)
Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0 [ Time Frame: 30 days ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: May 3, 2013)
Safety [ Time Frame: 30 days ]
Perioperative complications and mortality
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 29, 2019)
Patients Underwent a Successful Resection [ Time Frame: 30 days ]
Number of patients who underwent a successful resection which is measured by an accurate and appropriate resection in a given timeline
Original Secondary Outcome Measures  ICMJE
 (submitted: May 3, 2013)
Efficacy [ Time Frame: 30 days ]
Accurate and appropriate resection in a given timeline
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Percutaneous Image Guided Video-Assisted Thoracic Surgery (VATS) Resection of Lung Lesions
Official Title  ICMJE Percutaneous Image Guided Video Assisted Thoracic Surgery (VATS) Resection of Lung Lesions
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.
Detailed Description This is a phase II protocol to determine the safety and feasibility of image guided CT marking for resection of small lung nodules. This is relevant because many such nodules are hard to localize for minimally invasive lung resection. It is hoped that this technology using fluoro CT capability available now in most operating room will improve safety and reliability of thoracic surgery.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Lung Cancer
Intervention  ICMJE Procedure: Video-Assisted Thoracic Surgery (VATS) wedge resection
Other Name: Nodules marked with fiducials such as Kopan needles under CT fluoroscopy followed by VATS wedge resection.
Study Arms  ICMJE Experimental: CT Marking and VATS lung wedge resection
Each 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.
Intervention: Procedure: Video-Assisted Thoracic Surgery (VATS) wedge resection
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 3, 2013)
25
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2017
Actual Primary Completion Date September 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • peripheral lung nodules < 3cm in size
  • Surgical candidate

Exclusion Criteria:

  • Non surgical candidate
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01847209
Other Study ID Numbers  ICMJE 2012P001915
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Raphael Bueno, Brigham and Women's Hospital
Study Sponsor  ICMJE Brigham and Women's Hospital
Collaborators  ICMJE Siemens Medical Solutions USA - CSG
Investigators  ICMJE
Principal Investigator: Raphael Bueno, M.D. Brigham and Women's Hospital
PRS Account Brigham and Women's Hospital
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP