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

Study Overview
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Brief Summary
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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.

Official Title
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A Feasibility/Pilot Study of a Modular Video Augmentation System for Image-Guided Endoscopic Skull Base Surgery

Conditions
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Feasibility of Video Augmentation System, Value of Video Augmentation Navigation

Intervention / Treatment
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* Device: Video Augmentation


Participation Criteria
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Eligibility Criteria
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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;

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Video Augmentation<br>Qualitative assessment of the value of video-based navigation system | Device: Video Augmentation<br>* Assessment of value of video-based navigation system<br>* Other names: Interfaces with Medtronic Stealthstation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Qualitative Assessment of Video Augmentation Software by Post-operative Survey of Neurosurgeon and Otolaryngologist | 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. | Assessment is immediate, following operation. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Data Recording for Retrospective Analysis | 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 | Data is recorded during case. |