A Feasibility Study of a Modular Video Augmentation System for Image-Guided Skull Base Surgery
|Feasibility of Video Augmentation System Value of Video Augmentation Navigation||Device: Video Augmentation|
|Study Design:||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|
- 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.
- = 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. ]
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|
|Study Completion Date:||January 2013|
|Primary Completion Date:||January 2013 (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
|United States, Maryland|
|Johns Hopkins Hospital|
|Baltimore, Maryland, United States, 21287|
|Principal Investigator:||Gary L Gallia, M.D., Ph.D.||Johns Hopkins Hospital Department of Neurosurgery|