A Feasibility Study of a Modular Video Augmentation System for Image-Guided Skull Base Surgery
Recruitment status was Recruiting
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.
Feasibility of Video Augmentation System
Value of Video Augmentation Navigation
Device: Video Augmentation
|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|
- 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.
- = Significant hindrance / Negative effect;
- = Minor hindrance / Slightly negative effect;
- = Not helpful / No benefit or hindrance;
- = Somewhat helpful / Slight benefit;
- = Very helpful / Major benefit. Evaluation of safety is determined by collecting data regarding additional time, personnel and possible contamination.
- 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:
- - Tracked Endoscope information.
- - Video from endoscopy
- - Planning CT/MRI data
|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)|
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01591954
|Contact: Gary Gallia, MD. PhDfirstname.lastname@example.org|
|United States, Maryland|
|Johns Hopkins Hospital||Recruiting|
|Baltimore, Maryland, United States, 21287|
|Contact: Gary Gallia, MD. PhD 410-614-0585 email@example.com|
|Principal Investigator:||Gary L Gallia, M.D., Ph.D.||Johns Hopkins Hospital Department of Neurosurgery|