Feasibility of Video Augmentation SystemNCT01591954
A Feasibility Study of a Modular Video Augmentation System for Image-Guided Skull Base Surgery
A study testing Video Augmentation in people with Feasibility of Video Augmentation System and Value of Video Augmentation Navigation, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Feasibility of Video Augmentation System, Value of Video Augmentation Navigation
- What is being tested?
- Video Augmentation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2012to Jan 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Major medical or psychiatric illness which, in the investigator's opinion, would prevent completion of the procedure;
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Feasibility/Pilot Study of a Modular Video Augmentation System for Image-Guided Endoscopic Skull Base Surgery
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.
- Being tested
- Video Augmentation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video AugmentationDevice
Also called Interfaces with Medtronic Stealthstation
Assessment of value of video-based navigation system
| Study group | Role | What they receive |
|---|---|---|
| Video Augmentation | Experimental | Qualitative assessment of the value of video-based navigation system Receives: Device: Video Augmentation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Assessment is immediate, following operation.
Secondary outcomes (1)
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
Measured: Data is recorded during case.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2012 (estimated)
- Study startJan 2012
- Primary completionJan 2013
- Study completionJan 2013
Why it stopped: 3rd party proprietary software issue
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Feasibility of Video Augmentation SystemStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gary L Gallia, M.D., Ph.D., Principal investigator, Johns Hopkins Hospital Department of Neurosurgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01591954
- Sponsor's protocol ID
- J11101
- Other IDs
- NA_00051786
- Status last verified
- Oct 2016
- First submitted
- 1 May 2012
- Last updated
- 1 Dec 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility/Pilot Study of a Modular Video Augmentation System for Image-Guided Endoscopic Skull Base Surgery
- ClinicalTrials.gov ID
- NCT01591954
- Acronym / sponsor ID
- J11101
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: 3rd party proprietary software issue
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 4 May 2012 (estimated)
- Results
- Posted 1 Dec 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Video Augmentation | Experimental | Device: Video AugmentationQualitative assessment of the value of video-based navigation system |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- Major medical or psychiatric illness which, in the investigator's opinion, would prevent completion of the procedure;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Video AugmentationAlso: Interfaces with Medtronic StealthstationAssessment of value of video-based navigation system | Device | Video Augmentation |
Primary outcome
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. 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.
1 secondary outcome
Data Recording for Retrospective Analysis
Time frame: Data is recorded during case.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gary L Gallia, M.D., Ph.D. principal investigator
Johns Hopkins Hospital Department of Neurosurgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Video Augmentation in people with Feasibility of Video Augmentation System and Value of Video Augmentation Navigation, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 1 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Dec 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Qualitative Assessment of Video Augmentation Software by Post-operative Survey of Neurosurgeon and Otolaryngologist (time frame: Assessment is immediate, following operation.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2016.