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A Feasibility Study of a Modular Video Augmentation System for Image-Guided Skull Base Surgery

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: NCT01591954
Recruitment Status : Terminated (3rd party proprietary software issue)
First Posted : May 4, 2012
Results First Posted : December 1, 2016
Last Update Posted : December 1, 2016
Sponsor:
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Study Description
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Brief Summary:
Current standard of care for complex head, neck and skull base surgery require navigation systems that allow instruments to be tracked optically or electromagnetically while registered to a patient's pre-operative X-ray computed tomography (CT) or magnetic resonance image (MRI). However, conventionally, the CT/MRI data is not registered with video endoscopy. Augmentation of endoscopic video by preoperative data can facilitate navigation around critical structures and robust target resection. The work presented here describes evaluation of a high definition (HD) video-overlay system for endonasal endoscopic skull base surgery. We adopt a modular design that can be extended for other video augmentation applications. The system supports fast automatic camera calibration, comparable in re-projection errors to standard camera calibration tools, while performing within appropriate run time for clinical use. Phantom studies have shown the registration accuracy of the system to be equivalent to that of conventional optical tracking. With this system we are proposing a clinical pilot study in a small number of patients at Johns Hopkins Hospital to evaluate basic feasibility and to gather qualitative assessment of the video augmentation system.

Condition or disease Intervention/treatment Phase
Feasibility of Video Augmentation System Value of Video Augmentation Navigation Device: Video Augmentation Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: A Feasibility/Pilot Study of a Modular Video Augmentation System for Image-Guided Endoscopic Skull Base Surgery
Study Start Date : January 2012
Actual Primary Completion Date : January 2013
Actual Study Completion Date : January 2013
Arms and Interventions
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Arm Intervention/treatment
Experimental: Video Augmentation
Qualitative assessment of the value of video-based navigation system
 Device: Video Augmentation
Assessment of value of video-based navigation system
Other Name: Interfaces with Medtronic Stealthstation


Outcome Measures
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Primary Outcome Measures :
  1. Qualitative Assessment of Video Augmentation Software by Post-operative Survey of Neurosurgeon and Otolaryngologist [ Time Frame: Assessment is immediate, following operation. ]

    The qualitative assessment of new video augmentation software by the three surgeons surveys the effect of video augmentation overlay on overall surgical confidence, procedure, approach, and visualization.

    1. = Significant hindrance / Negative effect;
    2. = Minor hindrance / Slightly negative effect;
    3. = Not helpful / No benefit or hindrance;
    4. = Somewhat helpful / Slight benefit;
    5. = Very helpful / Major benefit. Evaluation of safety is determined by collecting data regarding additional time, personnel and possible contamination.


Secondary Outcome Measures :
  1. Data Recording for Retrospective Analysis [ Time Frame: Data is recorded during case. ]

    The secondary outcome variable of this study is the data recorded by the video augmentation system during pertinent portions of the operation. We will be targeting steps in the procedure that would have the greatest benefit from an augmented video scene to be used later for further studies. Such data will form the subject of retrospective analysis of workflow.

    Three sets of data will be collected to be able to reconstruct the video scene for analysis of the system:

    1. - Tracked Endoscope information.
    2. - Video from endoscopy
    3. - Planning CT/MRI data


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:   Yes
Criteria

Inclusion Criteria:

  • Participants must be at least 18 years of age or older;
  • Have an existing clinically ordered CT image within 2 weeks of the study; or
  • Have an existing clinically ordered MR image within 2 weeks of the study;
  • Provide written informed consent after receiving a verbal and written explanation of the purpose and nature of this clinical study;
  • Be able to communicate effectively with clinical study personnel

Exclusion Criteria:

  • Major medical or psychiatric illness which, in the investigator's opinion, would prevent completion of the procedure;
Contacts and Locations
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Information from the National Library of Medicine

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): NCT01591954


Locations
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United States, Maryland
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Investigators
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Principal Investigator: Gary L Gallia, M.D., Ph.D. Johns Hopkins Hospital Department of Neurosurgery
More Information
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Responsible Party: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
ClinicalTrials.gov Identifier: NCT01591954    
Other Study ID Numbers: J11101
NA_00051786 ( Other Identifier: JHMIRB )
First Posted: May 4, 2012    Key Record Dates
Results First Posted: December 1, 2016
Last Update Posted: December 1, 2016
Last Verified: October 2016