Pathological Conditions, AnatomicalNCT02905344
Effectiveness of Using 3D Printed Models to Educate Otolaryngology (Ear, Nose, Nose and Throat (ENT)) Patients About Surgery: A Survey
An observational study of Pathological Conditions, Anatomical and Deviated Nasal Septum, run by University of Notre Dame at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pathological Conditions, Anatomical, Deviated Nasal Septum
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2015to Nov 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 100 adult patients considering sinus surgery
Who may be able to join
- Male and female subjects that are 18 years or older.
- Surgeon must have recommended nasal or sinus surgery
- Not excluded as a surgical candidate
Who cannot join
- Patients who or not able to read or understand English
Trial locations and contacts
1 site in 1 country.
United States1 site
Michiana ENT Specialty Center
South Bend, Indiana, 46635
About this study
Official title: The Effectiveness of Using 3D Printed Anatomically Accurate Models to Educate 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.
- Medical subject headings
- Pathological Conditions, Anatomical
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Control, no anatomical model used for description | |
| 2 | Anatomical model used for description |
What is being measured
The primary outcome is the main question the study is designed to answer.
Question: How did the doctor's visualization help you in your understanding of the surgery?
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2016 (estimated)
- Study startFeb 2015
- Primary completionNov 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pathological Conditions, AnatomicalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Notre Dame
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Douglas R Liepert, M.D., Principal investigator, Notre Dame
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02905344
- Sponsor's protocol ID
- 14-07-1962
- Status last verified
- Sep 2016
- First submitted
- 8 Sep 2016
- Last updated
- 19 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: The data will be freely shared upon email request.
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Using 3D Printed Anatomically Accurate Models to Educate Patients About Surgery: A Survey
- ClinicalTrials.gov ID
- NCT02905344
- Acronym / sponsor ID
- 14-07-1962
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of Notre DameUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 19 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Control, no anatomical model used for description |
| 2 | – | –Anatomical model used for description |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 100 adult patients considering sinus surgery
Key inclusion criteria (3 listed)
- Male and female subjects that are 18 years or older.
- Surgeon must have recommended nasal or sinus surgery
- Not excluded as a surgical candidate
Key exclusion criteria (1 listed)
- Patients who or not able to read or understand English
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Question: How did the doctor's visualization help you in your understanding of the surgery?
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2016.
- Individual participant dataSharing planned: Yes. The data will be freely shared upon email request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Douglas R Liepert, M.D. principal investigator
Notre Dame
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pathological Conditions, Anatomical and Deviated Nasal Septum, run by University of Notre Dame at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Question: How did the doctor's visualization help you in your understanding of the surgery? (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2016.