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Effectiveness of Using 3D Printed Models to Educate Otolaryngology (Ear, Nose, Nose and Throat (ENT)) Patients About Surgery: A Survey

Sponsor
University of Notre Dame (Other)
Overall Status
Completed
CT.gov ID
NCT02905344
Collaborator
(none)
100
Enrollment
1
Location
9
Duration (Months)
11.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Within the Ear, Nose, and Throat (ENT) medical space, a relatively small number of patients follow through with elective surgeries to fix ailments like a deviated septum or occluded sinus passage. Patient understanding of their diagnosis and treatment plan is integral to compliance, which ultimately yields improved medical outcomes and better quality of life. Here the investigators report the usage of advanced inkjet 3D printing methods to develop a multimaterial replica of the patient's nasal sinus anatomy, derived from clinical X-ray Computed Tomography (CT) data. The final patient education model was developed over several iterations to optimize material properties, anatomical accuracy and overall display. A two arm, single center, randomized, prospective study was then performed in which 50 ENT surgical candidates (and an associated control group, n = 50) were given an explanation of their anatomy, disease state, and treatment options using the education model as an aid. Each patient was then surveyed for their self-rated understanding of their anatomy, disease, and treatment options.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    100 participants
    Time Perspective:
    Prospective
    Official Title:
    The Effectiveness of Using 3D Printed Anatomically Accurate Models to Educate Patients About Surgery: A Survey
    Study Start Date :
    Feb 1, 2015
    Actual Primary Completion Date :
    Nov 1, 2015
    Actual Study Completion Date :
    Nov 1, 2015

    Arms and Interventions

    Arm Intervention/Treatment
    1

    Control, no anatomical model used for description
    2

    Anatomical model used for description

    Outcome Measures

    Primary Outcome Measures

    1. Question: How did the doctor's visualization help you in your understanding of the surgery? [1 year]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Male and female subjects that are 18 years or older.

    • Surgeon must have recommended nasal or sinus surgery

    • Not excluded as a surgical candidate

    Exclusion Criteria:
    • Patients who or not able to read or understand English

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Michiana ENT Specialty Center South Bend Indiana United States 46635

    Sponsors and Collaborators

    • University of Notre Dame

    Investigators

    • Principal Investigator: Douglas R Liepert, M.D., Notre Dame

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Notre Dame
    ClinicalTrials.gov Identifier:
    NCT02905344
    Other Study ID Numbers:
    • 14-07-1962
    First Posted:
    Sep 19, 2016
    Last Update Posted:
    Sep 19, 2016
    Last Verified:
    Sep 1, 2016
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Additional relevant MeSH terms:
    Pathological Conditions, Anatomical

    Study Results

    No Results Posted as of Sep 19, 2016