Computer SimulationPhase 2NCT00887185
Validation/Dissemination Of A Temporal Bone Dissection Simulator
A Phase 2 study testing Simulator training for temporal bone surgery in people with Computer Simulation and Education, run by Gregory Wiet at 1 site in United States.
Trial summary
Designed to test the efficacy of a computer based virtual simulation for teaching ear surgery. Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Computer Simulation, Education
- What is being tested?
- Simulator training for temporal bone surgery
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2006to Aug 2011
- Phase
- Phase 2
- 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 20 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Enrolled in residency for ear, nose and throat training or medical student interested in ear, nose and throat training.
Who cannot join
- Not enrolled in ENT training program or interest in ENT training.
Trial locations and contacts
1 site in 1 country.
About this study
Designed to test the efficacy of a computer based virtual simulation for teaching ear surgery.
Read the detailed description
This research is designed to test the efficacy of a computer based virtual simulation for teaching ear surgery. Subjects will be randomized to training in the usual fashion and training in the simulation environment. Subjects performance will be tested in a standard fashion by dissecting cadaveric temporal bones (human ears) before and after training. The subjects will also perform a dissection in the virtual environment before and after training. The results will be tabulated to compare the different training arms. There is minimal risk associated with the projects and is limited to exposure to cadaveric material. Current training techniques utilize cadaveric material so exposure to this type of material is already a part of the standard training process and this study should not constitute an increased risk beyond what is encountered during their regular training. Demographic information will be obtained for each of the study subject on age, sex, information regarding previous otologic training, year of training and prior experience using computers. The anticipated benefits to society will be that future otologic surgeons can obtain operative experience in a controlled and non threatening environment. They will have access to a greater number of variations in pathology. This will allow each novice surgeon to obtain significantly more experience outside the operating room prior to working with live patients. This will result in less risk to the patient and better trained ear surgeons.
- Conditions
- Computer Simulation, Education
- Being tested
- Simulator training for temporal bone surgery
- Keywords
- Surgical Simulation, Surgical skills training, Temporal bone surgery, Computer simulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Simulator training for temporal bone surgeryOther
Also called Simulator training, Surgical training
Subjects in experimental arm are asked to spend 2 weeks practicing temporal bone surgical procedures using a computer simulation.
| Study group | Role | What they receive |
|---|---|---|
| 1 - Traditional training | Active comparator | Temporal bone dissection training in cadaveric laboratory. Subjects are provided 2 cadaveric temporal bones and asked to spend 2 weeks practicing the surgical technique of complete mastoidectomy with facial recess approach. Receives: Other: Simulator training for temporal bone surgery |
| 2 Simulator training | Experimental | Subjects perform temporal bone surgical dissection training on a simulator. Receives: Other: Simulator training for temporal bone surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance on temporal bone dissection.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2009 (estimated)
- Study startOct 2006
- Primary completionAug 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Computer SimulationStudies 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 2
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gregory Wiet
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Responsible party
- Sponsor-investigator, Gregory Wiet, Ohio State University
- Investigators
- Gregory J Wiet, MD, Principal investigator, The Ohio State University, Nationwide Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00887185
- Sponsor's protocol ID
- 2006H0194
- Other IDs
- 5R01DC006458-05, NIH Grant 5R01DC006458-05
- Status last verified
- Sep 2011
- First submitted
- 21 Apr 2009
- Last updated
- 27 Sep 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Wiet GJ, Schmalbrock P, Powell K, Stredney D. Use of ultra-high-resolution data for temporal bone dissection simulation. Otolaryngol Head Neck Surg. 2005 Dec;133(6):911-5. doi: 10.1016/j.otohns.2005.05.655.
PubMed 16360513Stredney D, Wiet GJ, Bryan J, Sessanna D, Murakami J, Schmalbrock P, Powell K, Welling B. Temporal bone dissection simulation--an update. Stud Health Technol Inform. 2002;85:507-13.
PubMed 15458142Wiet GJ, Stredney D, Sessanna D, Bryan JA, Welling DB, Schmalbrock P. Virtual temporal bone dissection: an interactive surgical simulator. Otolaryngol Head Neck Surg. 2002 Jul;127(1):79-83. doi: 10.1067/mhn.2002.126588.
PubMed 12161735Fernandez SA, Wiet GJ, Butler NN, Welling B, Jarjoura D. Reliability of surgical skills scores in otolaryngology residents: analysis using generalizability theory. Eval Health Prof. 2008 Dec;31(4):419-36. doi: 10.1177/0163278708324444. Epub 2008 Oct 7.
PubMed 18842619Butler NN, Wiet GJ. Reliability of the Welling scale (WS1) for rating temporal bone dissection performance. Laryngoscope. 2007 Oct;117(10):1803-8. doi: 10.1097/MLG.0b013e31811edd7a.
PubMed 17721407
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation/Dissemination Of A Temporal Bone Dissection Simulator
- ClinicalTrials.gov ID
- NCT00887185
- Acronym / sponsor ID
- 2006H0194
- Conditions
- Computer Simulation, Education
- Keywords
- Surgical Simulation, Surgical skills training, Temporal bone surgery, Computer simulation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Gregory WietUniversity, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Study start
- Oct 2006
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 23 Apr 2009 (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.
Designed to test the efficacy of a computer based virtual simulation for teaching ear surgery.
Detailed description
This research is designed to test the efficacy of a computer based virtual simulation for teaching ear surgery. Subjects will be randomized to training in the usual fashion and training in the simulation environment. Subjects performance will be tested in a standard fashion by dissecting cadaveric temporal bones (human ears) before and after training. The subjects will also perform a dissection in the virtual environment before and after training. The results will be tabulated to compare the different training arms. There is minimal risk associated with the projects and is limited to exposure to cadaveric material. Current training techniques utilize cadaveric material so exposure to this type of material is already a part of the standard training process and this study should not constitute an increased risk beyond what is encountered during their regular training. Demographic information will be obtained for each of the study subject on age, sex, information regarding previous otologic training, year of training and prior experience using computers. The anticipated benefits to society will be that future otologic surgeons can obtain operative experience in a controlled and non threatening environment. They will have access to a greater number of variations in pathology. This will allow each novice surgeon to obtain significantly more experience outside the operating room prior to working with live patients. This will result in less risk to the patient and better trained ear surgeons.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 - Traditional training | Active comparator | Other: Simulator training for temporal bone surgeryTemporal bone dissection training in cadaveric laboratory. Subjects are provided 2 cadaveric temporal bones and asked to spend 2 weeks practicing the surgical technique of complete mastoidectomy with facial recess approach. |
| 2 Simulator training | Experimental | Other: Simulator training for temporal bone surgerySubjects perform temporal bone surgical dissection training on a simulator. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Enrolled in residency for ear, nose and throat training or medical student interested in ear, nose and throat training.
Key exclusion criteria (1 listed)
- Not enrolled in ENT training program or interest in ENT training.
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 for temporal bone surgeryAlso: Simulator training, Surgical trainingSubjects in experimental arm are asked to spend 2 weeks practicing temporal bone surgical procedures using a computer simulation. | Other | 1 - Traditional training, 2 Simulator training |
Primary outcome
Performance on temporal bone dissection.
Time frame: 2 weeks
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 27 Sep 2011.
- Background: PubMed 16360513Wiet GJ, Schmalbrock P, Powell K, Stredney D. Use of ultra-high-resolution data for temporal bone dissection simulation. Otolaryngol Head Neck Surg. 2005 Dec;133(6):911-5. doi: 10.1016/j.otohns.2005.05.655.
- Background: PubMed 15458142Stredney D, Wiet GJ, Bryan J, Sessanna D, Murakami J, Schmalbrock P, Powell K, Welling B. Temporal bone dissection simulation--an update. Stud Health Technol Inform. 2002;85:507-13.
- Background: PubMed 12161735Wiet GJ, Stredney D, Sessanna D, Bryan JA, Welling DB, Schmalbrock P. Virtual temporal bone dissection: an interactive surgical simulator. Otolaryngol Head Neck Surg. 2002 Jul;127(1):79-83. doi: 10.1067/mhn.2002.126588.
- Results publication: PubMed 18842619Fernandez SA, Wiet GJ, Butler NN, Welling B, Jarjoura D. Reliability of surgical skills scores in otolaryngology residents: analysis using generalizability theory. Eval Health Prof. 2008 Dec;31(4):419-36. doi: 10.1177/0163278708324444. Epub 2008 Oct 7.
- Results publication: PubMed 17721407Butler NN, Wiet GJ. Reliability of the Welling scale (WS1) for rating temporal bone dissection performance. Laryngoscope. 2007 Oct;117(10):1803-8. doi: 10.1097/MLG.0b013e31811edd7a.
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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.
Gregory J Wiet, MD principal investigator
The Ohio State University, Nationwide Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Simulator training for temporal bone surgery in people with Computer Simulation and Education, run by Gregory Wiet 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 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 27 Sep 2011. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 temporal bone dissection. (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00887185, which also lists 5 linked publications.
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 27 Sep 2011.