Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Virtual Temporal Bone Surgery: Defining and Translating Metrics

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2015 by Nationwide Children's Hospital
Ohio State University
Information provided by (Responsible Party):
Gregory Wiet, Nationwide Children's Hospital Identifier:
First received: December 13, 2011
Last updated: February 2, 2015
Last verified: February 2015

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.

Condition Intervention Phase
Focus: Otologic Surgery Training
Other: Simulator training with expert scoring
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Investigator)
Official Title: Virtual Temporal Bone Surgery: Defining and Translating Metrics

Further study details as provided by Nationwide Children's Hospital:

Primary Outcome Measures:
  • Performance on a set of validated metrics for temporal bone surgery. [ Time Frame: one year ] [ Designated as safety issue: No ]
    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.

Estimated Enrollment: 170
Study Start Date: July 2013
Estimated Study Completion Date: July 2016
Estimated Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Other: Simulator training with expert scoring
Residents will be trained using surgical simulation

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.


Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Specific knowledge of otologic surgery.

Exclusion Criteria:

  • request not to participate
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01493765

Contact: Gregory J Wiet, MD 614-722-6600

United States, California
UC Irvine Recruiting
Irvine, California, United States, 92868
Contact: Hamid Djilian         
Stanford Recruiting
Palo Alto, California, United States, 94305
Contact: Nikolas Blevins, MD         
United States, Iowa
Iowa Recruiting
Iowa City, Iowa, United States, 52242
Contact: Marlan Hansen, MD         
United States, Michigan
Henry Ford Recruiting
Detroit, Michigan, United States, 28322
Contact: Michael Seidman, MD         
United States, Mississippi
Mississippi Recruiting
Jackson, Mississippi, United States, 39216
Contact: Thomas Eby, MD         
United States, New York
Albert Einstein Recruiting
Bronx, New York, United States, 10467
Contact: Elizabeth Dinces, MD         
United States, North Carolina
Duke Recruiting
Durham, North Carolina, United States, 27710
Contact: Debra Tucci, MD         
United States, Ohio
The Ohio State University Recruiting
Columbus, Ohio, United States, 43210
Contact: Gregory wiet, MD    614-722-6600      
Sub-Investigator: Don Stredney, MS         
United States, Texas
UT Southwestern Recruiting
Dallas, Texas, United States, 75390
Contact: Walter Kutz, MD         
Baylor Recruiting
Houston, Texas, United States, 77030
Contact: Jeff Vrabec, MD         
Sponsors and Collaborators
Nationwide Children's Hospital
Ohio State University
  More Information

No publications provided

Responsible Party: Gregory Wiet, Associate Professor of Otolaryngology and Biomedical Informatics, Nationwide Children's Hospital Identifier: NCT01493765     History of Changes
Other Study ID Numbers: R01 DC011321-01 A1
Study First Received: December 13, 2011
Last Updated: February 2, 2015
Health Authority: United States: Institutional Review Board processed this record on March 03, 2015