Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| NA_00051786 | Other Identifier | JHMIRB |
Not provided
Not provided
Not provided
3rd party proprietary software issue
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Video Augmentation | Experimental | Qualitative assessment of the value of video-based navigation system |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Video Augmentation | Device | Assessment of value of video-based navigation system |
|
| 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.
| Assessment is immediate, following operation. |
| 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:
|
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Gary L Gallia, M.D., Ph.D. | Johns Hopkins Hospital Department of Neurosurgery | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins Hospital | Baltimore | Maryland | 21287 | United States |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Video Augmentation | Qualitative assessment of the value of video-based navigation system Video Augmentation: Assessment of value of video-based navigation system |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Video Augmentation | Qualitative assessment of the value of video-based navigation system Video Augmentation: Assessment of value of video-based navigation system |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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.
| 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. | Posted | Assessment is immediate, following operation. |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Video Augmentation | Qualitative assessment of the value of video-based navigation system Video Augmentation: Assessment of value of video-based navigation system |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jeffrey H. Siewerdsen, PhD / Professor of Biomedical Engineering | Department of Biomedical Engineering, Johns Hopkins University | 443-287-6269 | jeff.siewerdsen@jhu.edu |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Data is recorded during case. |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG000 |
| Video Augmentation |
Qualitative assessment of the value of video-based navigation system Video Augmentation: Assessment of value of video-based navigation system |
|
| 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:
| 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. | Posted | Data is recorded during case. |
|
|
| 0 |
| 1 |
| 0 |
| 1 |
Not provided
Not provided
Not provided