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

NCT ID: NCT02905344

Last Updated: 2016-09-19

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-02-28
• Study Completion Date: 2015-11-30

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.

Conditions

Pathological Conditions, Anatomical; Deviated Nasal Septum

Study Design

• Study Time Perspective: PROSPECTIVE

Study Groups

1

Control, no anatomical model used for description

No interventions assigned to this group

2

Anatomical model used for description

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Notre Dame

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Douglas R Liepert, M.D.

Role: PRINCIPAL_INVESTIGATOR

Notre Dame

Locations

Michiana ENT Specialty Center

South Bend, Indiana, United States

Countries

United States

Other Identifiers

14-07-1962

Identifier Type: -

Identifier Source: org_study_id