Feasibility of Video Augmentation System, Value of Video Augmentation Navigation
Conditions
Brief summary
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.
Interventions
DEVICEVideo Augmentation
Assessment of value of video-based navigation system
Sponsors
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Qualitative Assessment of Video Augmentation Software by Post-operative Survey of Neurosurgeon and Otolaryngologist | 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. 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
| Measure | Time frame | Description |
|---|---|---|
| Data Recording for Retrospective Analysis | 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: 1. \- Tracked Endoscope information. 2. \- Video from endoscopy 3. \- Planning CT/MRI data |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Video Augmentation Qualitative assessment of the value of video-based navigation system
Video Augmentation: Assessment of value of video-based navigation system | 1 |
| Total | 1 |
Baseline characteristics
| Characteristic | Video Augmentation |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants |
| Sex: Female, Male Female | 1 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 1 |
| serious Total, serious adverse events | 0 / 1 |
Outcome results
Primary
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. 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.
Time frame: Assessment is immediate, following operation.
Population: The study was terminated following 1 subject accrual. The system encountered basic software incompatibility and would not function reliably. The problem could not be resolved even with extensive technical troubleshooting, so the study was terminated. Data was collected for one participant but could not be analyzed due to software incompatibility.
Secondary
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: 1. \- Tracked Endoscope information. 2. \- Video from endoscopy 3. \- Planning CT/MRI data
Time frame: Data is recorded during case.
Population: The study was terminated following 1 subject accrual. The system encountered basic software incompatibility and would not function reliably. The problem could not be resolved even with extensive technical troubleshooting, so the study was terminated. Data was collected for one participant but could not be analyzed due to software incompatibility.