Focus: Otologic Surgery TrainingNCT01493765
Virtual Temporal Bone Surgery: Defining and Translating Metrics
An observational study of Focus: Otologic Surgery Training, run by Nationwide Children's Hospital at 10 sites in United States.
Trial summary
The goal of this project is to improve the efficiency of training and assessment of technical skill in surgical treatment of otologic disease. Through previous funding, we have developed an intuitive virtual simulation environment to be used as an adjuvant for teaching temporal bone surgery. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Focus: Otologic Surgery Training
- What is being tested?
- Simulator training with expert scoring
- How many people
- 96 participants
- Where
- 10 sitesUnited States
- Study dates
- Jul 2013to 1 Jul 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Novice otology surgeons
Who may be able to join
- Specific knowledge of otologic surgery.
Who cannot join
- request not to participate
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
The Ohio State University
Columbus, Ohio, 43210
UT Southwestern
Dallas, Texas, 75390
Henry Ford
Detroit, Michigan, 28322
Duke
Durham, North Carolina, 27710
Baylor
Houston, Texas, 77030
Iowa
Iowa City, Iowa, 52242
UC Irvine
Irvine, California, 92868
Mississippi
Jackson, Mississippi, 39216
Stanford
Palo Alto, California, 94305
Albert Einstein
The Bronx, New York, 10467
About this study
The goal of this project is to improve the efficiency of training and assessment of technical skill in surgical treatment of otologic disease. Through previous funding, we have developed an intuitive virtual simulation environment to be used as an adjuvant for teaching temporal bone surgery. Using direct-volume visualization techniques with integrated stereoscopic display, haptic (force) feedback, and aural simulation, we have achieved a straightforward, low-cost learning environment ready for translation into a practical training and assessment tool. This application challenges and seeks to shift current practice in clinical training by translating the simulation environment into a vehicle for curriculum development, technical skills assessment, and dissemination. The intent is to provide more accessible, inexpensive, safe, and deliberate practice with objective and continuous quantitative, objective assessment in the early stages of training.
Read the detailed description
The aims of this research include: 1) definition of standardized metrics for otological surgical techniques, 2) the translation of those standards into objective criteria for use in a computer synthesized surgical environment, and 3) the correlation between expert evaluation and computer automated assessment of resident proficiency.
The interactions will be computer-based and include:
Experts will learn to use the system so that they can evaluate the quality of translation of metrics to the simulation environment.
Evaluations will be in the form of anonymous web-based surveys. Experts serve as a focus group.
Residents will use the simulation environment to perform surgical procedures on virtual specimens. Residents will then evaluate the quality of the simulation environment via anonymous web-based surveys.
Experts will use the simulation environment to evaluate and rate the residents performance.
The computer environment will be used to automatically assess and rate the residents performance.
Expert and computer assessment will be compared.
- Conditions
- Focus: Otologic Surgery Training
- Being tested
- Simulator training with expert scoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Simulator training with expert scoringOther
Residents will be trained using surgical simulation
| Study group | Role | What they receive |
|---|---|---|
| Benchmarking | All resident study subjects will drill virtual temporal bones within the computer based system. The performance data will be used to validate the rating metrics and computer scoring process. Receives: Other: Simulator training with expert scoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance on a set of validated metrics for temporal bone surgery.
A collection of metrics designed to measure technical performance during a mastoidectomy will be validated by expert survey. These metrics will be translated to an automated system within the surgical simulation system. Resident subjects will be asked to perform the surgical procedure (mastoidectomy) within the simulation. Experts will then rate the playback of the performances using the validated metrics. These results will be compared to the automated scoring system. A conclusion will be drawn about the accuracy of the automated process compared to the expert rated process.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2011 (estimated)
- Study startJul 2013
- Primary completion1 Jul 2016
- Study completion1 Jul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Focus: Otologic Surgery TrainingStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nationwide Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD), Ohio State University
- Responsible party
- Principal investigator, Gregory Wiet, Nationwide Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01493765
- Sponsor's protocol ID
- R01DC011321-01A1
- Status last verified
- Jan 2017
- First submitted
- 13 Dec 2011
- Last updated
- 31 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Temporal Bone Surgery: Defining and Translating Metrics
- ClinicalTrials.gov ID
- NCT01493765
- Acronym / sponsor ID
- R01DC011321-01A1
- Conditions
- Focus: Otologic Surgery Training
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Nationwide Children's HospitalUniversity, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD), Ohio State University
- Study start
- Jul 2013
- Primary completion
- 1 Jul 2016 (actual)
- Study completion
- 1 Jul 2016 (actual)
- First posted
- 16 Dec 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this project is to improve the efficiency of training and assessment of technical skill in surgical treatment of otologic disease. Through previous funding, we have developed an intuitive virtual simulation environment to be used as an adjuvant for teaching temporal bone surgery. Using direct-volume visualization techniques with integrated stereoscopic display, haptic (force) feedback, and aural simulation, we have achieved a straightforward, low-cost learning environment ready for translation into a practical training and assessment tool. This application challenges and seeks to shift current practice in clinical training by translating the simulation environment into a vehicle for curriculum development, technical skills assessment, and dissemination. The intent is to provide more accessible, inexpensive, safe, and deliberate practice with objective and continuous quantitative, objective assessment in the early stages of training.
Detailed description
The aims of this research include: 1) definition of standardized metrics for otological surgical techniques, 2) the translation of those standards into objective criteria for use in a computer synthesized surgical environment, and 3) the correlation between expert evaluation and computer automated assessment of resident proficiency.
The interactions will be computer-based and include:
Experts will learn to use the system so that they can evaluate the quality of translation of metrics to the simulation environment.
Evaluations will be in the form of anonymous web-based surveys. Experts serve as a focus group.
Residents will use the simulation environment to perform surgical procedures on virtual specimens. Residents will then evaluate the quality of the simulation environment via anonymous web-based surveys.
Experts will use the simulation environment to evaluate and rate the residents performance.
The computer environment will be used to automatically assess and rate the residents performance.
Expert and computer assessment will be compared.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Benchmarking | – | Other: Simulator training with expert scoringAll resident study subjects will drill virtual temporal bones within the computer based system. The performance data will be used to validate the rating metrics and computer scoring process. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Novice otology surgeons
Key inclusion criteria (1 listed)
- Specific knowledge of otologic surgery.
Key exclusion criteria (1 listed)
- request not to participate
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 |
|---|---|---|
| Simulator training with expert scoringResidents will be trained using surgical simulation | Other | Benchmarking |
Primary outcome
Performance on a set of validated metrics for temporal bone surgery.
Time frame: one year
A collection of metrics designed to measure technical performance during a mastoidectomy will be validated by expert survey. These metrics will be translated to an automated system within the surgical simulation system. Resident subjects will be asked to perform the surgical procedure (mastoidectomy) within the simulation. Experts will then rate the playback of the performances using the validated metrics. These results will be compared to the automated scoring system. A conclusion will be drawn about the accuracy of the automated process compared to the expert rated process.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2017.
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.
The record lists no contact. Use the official record to reach the sponsor.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Focus: Otologic Surgery Training, run by Nationwide Children's Hospital at 10 sites 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 1 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: finished, as of the sponsor's last update on 31 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Performance on a set of validated metrics for temporal bone surgery. (time frame: one year). 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 31 Jan 2017.