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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

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Lung Cancer
Intervention Procedure: Video-Assisted Thoracic Surgery (VATS) wedge resection
Enrollment 25
Recruitment Details The recruitment for this study was completed in the medical clinic and started in April 2013 and included in September 2014.
Pre-assignment Details  
Arm/Group Title CT Marking and VATS Lung Wedge Resection
Hide Arm/Group Description

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.

Video-Assisted Thoracic Surgery (VATS) wedge resection

Period Title: Overall Study
Started 25
Completed 23
Not Completed 2
Reason Not Completed
Withdrawal by Subject             1
No lung nodule found on intraop CT scan             1
Arm/Group Title CT Marking and VATS Lung Wedge Resection
Hide Arm/Group Description

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.

Video-Assisted Thoracic Surgery (VATS) wedge resection

Overall Number of Baseline Participants 23
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 23 participants
<=18 years
0
   0.0%
Between 18 and 65 years
12
  52.2%
>=65 years
11
  47.8%
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 23 participants
65
(19 to 80)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 23 participants
Female
16
  69.6%
Male
7
  30.4%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 23 participants
23
 100.0%
1.Primary Outcome
Title Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0
Hide Description 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.
Time Frame 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title CT Marking and VATS Lung Wedge Resection
Hide Arm/Group Description:

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.

Video-Assisted Thoracic Surgery (VATS) wedge resection

Overall Number of Participants Analyzed 23
Measure Type: Count of Participants
Unit of Measure: Participants
1
   4.3%
2.Secondary Outcome
Title Patients Underwent a Successful Resection
Hide Description Number of patients who underwent a successful resection which is measured by an accurate and appropriate resection in a given timeline
Time Frame 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title CT Marking and VATS Lung Wedge Resection
Hide Arm/Group Description:

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.

Video-Assisted Thoracic Surgery (VATS) wedge resection

Overall Number of Participants Analyzed 23
Measure Type: Count of Participants
Unit of Measure: Participants
23
 100.0%
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title CT Marking and VATS Lung Wedge Resection
Hide Arm/Group Description

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.

Video-Assisted Thoracic Surgery (VATS) wedge resection

All-Cause Mortality
CT Marking and VATS Lung Wedge Resection
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
CT Marking and VATS Lung Wedge Resection
Affected / at Risk (%) # Events
Total   0/23 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
CT Marking and VATS Lung Wedge Resection
Affected / at Risk (%) # Events
Total   1/23 (4.35%)    
Surgical and medical procedures   
Received increased radiation dose [1]  1/23 (4.35%)  1
[1]
Patient received an increase dose of radiation than what was estimated in the protocol. The dose given to the patient is not dangerous and is equivalent to 2-3 CT scans The patient has done well and has had no adverse effects.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Raphael Bueno
Organization: Brigham and Women's Hospital
Phone: 617-732-8148
EMail: rbueno@partners.org
Layout table for additonal information
Responsible Party: Raphael Bueno, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT01847209    
Other Study ID Numbers: 2012P001915
First Submitted: May 2, 2013
First Posted: May 6, 2013
Results First Submitted: January 4, 2017
Results First Posted: April 29, 2019
Last Update Posted: April 29, 2019