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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2012 by Sidney Kimmel Comprehensive Cancer Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT01591954
First received: May 1, 2012
Last updated: May 2, 2012
Last verified: May 2012
  Purpose

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 Intervention
Feasibility of Video Augmentation System
Value of Video Augmentation Navigation
Device: Video Augmentation

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: A Feasibility/Pilot Study of a Modular Video Augmentation System for Image-Guided Endoscopic Skull Base Surgery

Resource links provided by NLM:


Further study details as provided by Sidney Kimmel Comprehensive Cancer Center:

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

    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:
  • Data Recording for Retrospective Analysis [ Time Frame: Data is recorded during case. ] [ Designated as safety issue: No ]

    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


Estimated Enrollment: 15
Study Start Date: January 2012
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01591954

Contacts
Contact: Gary Gallia, MD. PhD 410.614.0585 ggallia1@jhmi.edu

Locations
United States, Maryland
Johns Hopkins Hospital Recruiting
Baltimore, Maryland, United States, 21287
Contact: Gary Gallia, MD. PhD    410-614-0585    ggallia1@jhmi.edu   
Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center
Investigators
Principal Investigator: Gary L Gallia, M.D., Ph.D. Johns Hopkins Hospital Department of Neurosurgery
  More Information

No publications provided

Responsible Party: Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT01591954     History of Changes
Other Study ID Numbers: J11101, NA_00051786
Study First Received: May 1, 2012
Last Updated: May 2, 2012
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on November 24, 2014