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

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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Lung Cancer Procedure: Video-Assisted Thoracic Surgery (VATS) wedge resection Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Percutaneous Image Guided Video Assisted Thoracic Surgery (VATS) Resection of Lung Lesions
Study Start Date : April 2013
Actual Primary Completion Date : September 2014
Actual Study Completion Date : December 2017

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Arms and Interventions
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Arm Intervention/treatment
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.
 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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Non surgical candidate
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01847209


Locations
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United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Brigham and Women's Hospital
Siemens Medical Solutions USA - CSG
Investigators
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Principal Investigator: Raphael Bueno, M.D. Brigham and Women's Hospital
More Information
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Publications:

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Responsible Party: Raphael Bueno, Associate Chief of Thoracic Surgery; Professor of Surgery, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT01847209    
Other Study ID Numbers: 2012P001915
First Posted: May 6, 2013    Key Record Dates
Results First Posted: April 29, 2019
Last Update Posted: April 29, 2019
Last Verified: January 2019
Keywords provided by Raphael Bueno, Brigham and Women's Hospital:
lung nodule
lung cancer
lung mass
Additional relevant MeSH terms:
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Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
 Neoplasms
Lung Diseases
Respiratory Tract Diseases