- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01493765
Virtual Temporal Bone Surgery: Defining and Translating Metrics
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
California
-
Irvine, California, United States, 92868
- UC Irvine
-
Palo Alto, California, United States, 94305
- Stanford
-
-
Iowa
-
Iowa City, Iowa, United States, 52242
- Iowa
-
-
Michigan
-
Detroit, Michigan, United States, 28322
- Henry Ford
-
-
Mississippi
-
Jackson, Mississippi, United States, 39216
- Mississippi
-
-
New York
-
Bronx, New York, United States, 10467
- Albert Einstein
-
-
North Carolina
-
Durham, North Carolina, United States, 27710
- Duke
-
-
Ohio
-
Columbus, Ohio, United States, 43210
- The Ohio State University
-
-
Texas
-
Dallas, Texas, United States, 75390
- UT Southwestern
-
Houston, Texas, United States, 77030
- Baylor
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Specific knowledge of otologic surgery.
Exclusion Criteria:
- request not to participate
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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.
|
Residents will be trained using surgical simulation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
one year
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- R01DC011321-01A1 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Focus: Otologic Surgery Training
-
Le Hong LiemNot yet recruitingPrimary Condition/Focus: Cardiopulmonary Resuscitation Training
-
Dr Ulrik McCarthy PerssonCompletedFocus of Study is Effects of Neuromuscular TrainingIreland
-
Ewha Womans UniversityCompletedPostural Balance | Focus of Study is Effects of Neuromuscular Training | PilatesSouth Korea
-
University of PennsylvaniaNational Center for Complementary and Integrative Health (NCCIH)CompletedNo Condition | Focus is Neural Effects of Mindfulness Training on AttentionUnited States
-
Asalus Medical Instruments LimitedCompletedAssessment of a New Surgical Smoke Clearing Technology in Laparoscopic Cholecystectomy (Innervision)Focus: Surgical Smoke During Laparoscopic SurgeryUnited Kingdom
-
Arthroscopy Association of North AmericaCompletedStudy Focus: Simulation and Proficiency Based TrainingUnited States
-
Klinik für Allgemein- und Viszeralchirurgie, Department...WithdrawnLaparoscopy Training | Robotic Surgery TrainingSwitzerland
-
University Hospital, AntwerpCompleted
-
Hacettepe UniversityNot yet recruitingAdolescent | Exercise Training | External Focus (e.g., Performing the Exercise by Directing the Individual's Attention to a Laser Beam)
-
Odense University HospitalUniversity of Southern DenmarkCompletedOphthalmological Virtual Surgery Training
Clinical Trials on Simulator training with expert scoring
-
Alyn Pediatric & Adolescent Rehabilitation HospitalCompleted
-
University of Texas Southwestern Medical CenterNational Institute for Biomedical Imaging and Bioengineering (NIBIB)CompletedPredictive Validity of VLaHHSUnited States
-
Tongji HospitalCompleted
-
Gregory WietNational Institute on Deafness and Other Communication Disorders (NIDCD)CompletedEducation | Computer SimulationUnited States
-
University Hospital, Strasbourg, FranceCompleted
-
National Taiwan University HospitalCompletedPatients Undergoing ERCP ExaminationTaiwan
-
Medical University of ViennaCompleted
-
Fondazione Policlinico Universitario Agostino Gemelli...Not yet recruitingCoronary Artery DiseaseItaly
-
Sheba Medical CenterWithdrawn