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Validation/Dissemination Of A Temporal Bone Dissection Simulator

G

Gregory Wiet

Status and phase

Completed
Phase 2

Conditions

Education
Computer Simulation

Treatments

Other: Simulator training for temporal bone surgery

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT00887185
NIH Grant 5R01DC006458-05
5R01DC006458-05 (U.S. NIH Grant/Contract)
2006H0194

Details and patient eligibility

About

Designed to test the efficacy of a computer based virtual simulation for teaching ear surgery.

Full 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.

Enrollment

100 estimated patients

Sex

All

Ages

20 to 40 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Enrolled in residency for ear, nose and throat training or medical student interested in ear, nose and throat training.

Exclusion criteria

  • Not enrolled in ENT training program or interest in ENT training.

Trial design

Primary purpose

Health Services Research

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

100 participants in 2 patient groups

1 - Traditional training
Active Comparator group
Description:
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.
Treatment:
Other: Simulator training for temporal bone surgery
2 Simulator training
Experimental group
Description:
Subjects perform temporal bone surgical dissection training on a simulator.
Treatment:
Other: Simulator training for temporal bone surgery

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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