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OpenTrials
Completed

NCT Number: NCT02905344

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Michiana ENT Specialty Center

South Bend, Indiana, 46635, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

University of Notre Dame

Other

Registry information

Official study title

The Effectiveness of Using 3D Printed Anatomically Accurate Models to Educate Patients About Surgery: A Survey

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Sep 19, 2016
Registry last updated
Sep 19, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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