A Feasibility Study of a Modular Video Augmentation System for Image-Guided Skull Base Surgery
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|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
|Condition or disease||Intervention/treatment||Phase|
|Feasibility of Video Augmentation System Value of Video Augmentation Navigation||Device: Video Augmentation||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1 participants|
|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|
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
- 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
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
|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|