Trial Outcomes & Findings for A Feasibility Study of a Modular Video Augmentation System for Image-Guided Skull Base Surgery (NCT NCT01591954)
NCT ID: NCT01591954
Last Updated: 2016-12-01
Results Overview
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.
TERMINATED
NA
1 participants
Assessment is immediate, following operation.
2016-12-01
Participant Flow
Participant milestones
| Measure |
Video Augmentation
Qualitative assessment of the value of video-based navigation system
Video Augmentation: Assessment of value of video-based navigation system
|
|---|---|
|
Overall Study
STARTED
|
1
|
|
Overall Study
COMPLETED
|
1
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Feasibility Study of a Modular Video Augmentation System for Image-Guided Skull Base Surgery
Baseline characteristics by cohort
| Measure |
Video Augmentation
n=1 Participants
Qualitative assessment of the value of video-based navigation system
Video Augmentation: Assessment of value of video-based navigation system
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 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.
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
Outcome measures
Outcome data not reported
Adverse Events
Video Augmentation
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Jeffrey H. Siewerdsen, PhD / Professor of Biomedical Engineering
Department of Biomedical Engineering, Johns Hopkins University
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place