Satisfaction, PersonalNCT05410236
3D Printing in Airway Anatomy and Bronchoscopy Education
A study testing 3D bronchial tree model in people with Satisfaction, Personal, run by Fu Jen Catholic University at 1 site in Taiwan.
Trial summary
The main purpose of this study is to use 3D printing technology to make a human anatomical bronchial tree model, which is applied in medical education for medical students and students of the department of respiratory therapy. Most of the clinical teaching material is expansive and inaccessible. Read more about this study
- Who is it for?
- Ages 20 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Satisfaction, Personal
- What is being tested?
- 3D bronchial tree model
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jul 2022to 1 Dec 2022
- Phase
- Interventional
- 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 20 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Student of Fu Jen Catholic University.
Who cannot join
- Refused to participate in the study.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Fu Jen Catholic University Hospital, Fu Jen Catholic University
New Taipei City, 24352
About this study
Official title: The Application of Three-dimensional Printing in Airway Anatomy and Bronchoscopy Education
The main purpose of this study is to use 3D printing technology to make a human anatomical bronchial tree model, which is applied in medical education for medical students and students of the department of respiratory therapy. Most of the clinical teaching material is expansive and inaccessible. To promote accessibility of anatomy models and student learning effects in our school and hospital, we use the 3D printing technology to print bronchial tree model and apply it to anatomy and bronchoscopy education.
The present study expects some benefits that the use of printed bronchial trees for anatomy and bronchoscopy education. For example, it can reduce the cost of anatomy instruction, let students have their own anatomical model, and make the learning no longer limited to the anatomical classroom.
Read the detailed description
Three-dimensional (3D) printing is a technology used for the rapid production of customized physical objects. Bronchoscopy is a well-established, relatively safe procedure for both diagnostic and therapeutic interventions for a variety of pulmonary diseases. In this study, to enhance the quality of airway anatomy education and bronchoscopy training, we used 3D printing to develop a 3D bronchial tree model as a high-fidelity simulator for bronchoscopy and demonstrated its validity. We designed a 3D bronchial tree model containing 12 detachable parts and 11 adapter rings.
- Conditions
- Satisfaction, Personal
- Being tested
- 3D bronchial tree model
- Medical subject headings
- Personal Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D bronchial tree modelOther
A detachable 3D printed bronchial tree model
| Study group | Role | What they receive |
|---|---|---|
| Experimatal | Experimental | Learning anatomy with 3D bronchial tree model. Receives: Other: 3D bronchial tree model |
| Control group | No intervention | Learning anatomy without 3D bronchial tree model. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Examination score of pre-intervention
score of pre-intervention (maximun 100 and minimum 0), higher means a better outcome.
Measured: pre-intervention
Examination score of post-intervention
score of post-intervention (maximun 100 and minimum 0), higher means a better outcome.
Measured: immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2022
- Study start1 Jul 2022
- Primary completion31 Oct 2022
- Study completion1 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Satisfaction, PersonalStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fu Jen Catholic University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ke-Yun, Chao, Fu Jen Catholic University
- Investigators
- Ke-Yun Chao, MSc, Principal investigator, Fu Jen Catholic University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05410236
- Sponsor's protocol ID
- PL202008018V
- Status last verified
- Nov 2023
- First submitted
- 25 Feb 2022
- Last updated
- 13 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Application of Three-dimensional Printing in Airway Anatomy and Bronchoscopy Education
- ClinicalTrials.gov ID
- NCT05410236
- Acronym / sponsor ID
- PL202008018V
- Conditions
- Satisfaction, Personal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Fu Jen Catholic UniversityUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 31 Oct 2022 (actual)
- Study completion
- 1 Dec 2022 (actual)
- First posted
- 8 Jun 2022 (actual)
- 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.
The main purpose of this study is to use 3D printing technology to make a human anatomical bronchial tree model, which is applied in medical education for medical students and students of the department of respiratory therapy. Most of the clinical teaching material is expansive and inaccessible. To promote accessibility of anatomy models and student learning effects in our school and hospital, we use the 3D printing technology to print bronchial tree model and apply it to anatomy and bronchoscopy education.
The present study expects some benefits that the use of printed bronchial trees for anatomy and bronchoscopy education. For example, it can reduce the cost of anatomy instruction, let students have their own anatomical model, and make the learning no longer limited to the anatomical classroom.
Detailed description
Three-dimensional (3D) printing is a technology used for the rapid production of customized physical objects. Bronchoscopy is a well-established, relatively safe procedure for both diagnostic and therapeutic interventions for a variety of pulmonary diseases. In this study, to enhance the quality of airway anatomy education and bronchoscopy training, we used 3D printing to develop a 3D bronchial tree model as a high-fidelity simulator for bronchoscopy and demonstrated its validity. We designed a 3D bronchial tree model containing 12 detachable parts and 11 adapter rings.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimatal | Experimental | Other: 3D bronchial tree modelLearning anatomy with 3D bronchial tree model. |
| Control group | No intervention | –Learning anatomy without 3D bronchial tree model. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Student of Fu Jen Catholic University.
Key exclusion criteria (1 listed)
- Refused to participate in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3D bronchial tree modelA detachable 3D printed bronchial tree model | Other | Experimatal |
Primary outcome
Examination score of pre-intervention
Time frame: pre-intervention
score of pre-intervention (maximun 100 and minimum 0), higher means a better outcome.
Examination score of post-intervention
Time frame: immediately after the intervention
score of post-intervention (maximun 100 and minimum 0), higher means a better outcome.
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 13 Nov 2023.
- Individual participant dataSharing planned: No
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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.
Ke-Yun Chao, MSc principal investigator
Fu Jen Catholic University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3D bronchial tree model in people with Satisfaction, Personal, run by Fu Jen Catholic University at 1 site in Taiwan.
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 1 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 13 Nov 2023. 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 Taiwan. 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?
Examination score of pre-intervention (time frame: pre-intervention). The study lists 2 primary outcomes in all. 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 13 Nov 2023.