ArhiniaNCT02559050
Nasal Reconstruction Using a Customized 3D-printed Nasal Stent for Congenital Arhinia
An observational study of Arhinia, run by Seoul St. Mary's Hospital.
Trial summary
A 7-year-old arhinia patient receives nasal reconstruction with nasal cavity reconstruction and is aided with the application of a 3D-printed nasal stent to prevent nasal cavity constriction. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Arhinia
- What is being tested?
- Customized 3D-printed nasal stent
- How many people
- 1 participants
- Where
- No sites listed yet
- Study dates
- May 2013to Dec 2013
- 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 Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Study population: A 7-year-old male patient with congenital arhinia with no history of previous treatment.
Who may be able to join
- Single patient
- 7-year-old male
- Congenital arhinia
- No history of previous treatment
Who cannot join
- -
About this study
A 7-year-old arhinia patient receives nasal reconstruction with nasal cavity reconstruction and is aided with the application of a 3D-printed nasal stent to prevent nasal cavity constriction.
Read the detailed description
After reconstruction of a nasal cavity in the maxilla by burring using a navigation system, the patient required a nasal stent to prevent stenosis. However there was no conventional stent available. A 3D-printed silicone nasal stent was custom made for the cavity and inserted.
- Conditions
- Arhinia
- Being tested
- Customized 3D-printed nasal stent
- Medical subject headings
- Arrhinia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Customized 3D-printed nasal stentOther
Silicone stent with unconventional shape, 3D-printed based on patient's computed topographical images, to exactly fit newly made nasal cavity.
What is being measured
The primary outcome is the main question the study is designed to answer.
Nasal cavity diameter
Change from baseline nasal cavity diameter (measured by CT sagittal section, in millimeters)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2015 (estimated)
- Study startMay 2013
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ArhiniaStudies 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
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul St. Mary's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Pohang University of Science and Technology
- Responsible party
- Principal investigator, Jong-Won Rhie MD.PhD, Seoul St. Mary's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02559050
- Sponsor's protocol ID
- SM-AR-01
- Status last verified
- Sep 2015
- First submitted
- 26 Aug 2015
- Last updated
- 24 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Jung JW, Ha DH, Kim BY, Seo BF, Han HH, Kim DH, Rhie JW, Kim SW, Cho DW. Nasal Reconstruction Using a Customized Three-Dimensional-Printed Stent for Congenital Arhinia: Three-Year Follow-up. Laryngoscope. 2019 Mar;129(3):582-585. doi: 10.1002/lary.27335. Epub 2018 Sep 24.
PubMed 30247752
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nasal Reconstruction Using a Customized 3D-printed Nasal Stent for Congenital Arhinia
- ClinicalTrials.gov ID
- NCT02559050
- Acronym / sponsor ID
- SM-AR-01
- Conditions
- Arhinia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Seoul St. Mary's HospitalUniversity, hospital or other
- Collaborators
- Pohang University of Science and Technology
- Study start
- May 2013
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 24 Sep 2015 (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.
A 7-year-old arhinia patient receives nasal reconstruction with nasal cavity reconstruction and is aided with the application of a 3D-printed nasal stent to prevent nasal cavity constriction.
Detailed description
After reconstruction of a nasal cavity in the maxilla by burring using a navigation system, the patient required a nasal stent to prevent stenosis. However there was no conventional stent available. A 3D-printed silicone nasal stent was custom made for the cavity and inserted.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- A 7-year-old male patient with congenital arhinia with no history of previous treatment.
Key inclusion criteria (4 listed)
- Single patient
- 7-year-old male
- Congenital arhinia
- No history of previous treatment
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Customized 3D-printed nasal stentSilicone stent with unconventional shape, 3D-printed based on patient's computed topographical images, to exactly fit newly made nasal cavity. | Other | – |
Primary outcome
Nasal cavity diameter
Time frame: 6 months
Change from baseline nasal cavity diameter (measured by CT sagittal section, in millimeters)
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 24 Sep 2015.
- Derived from this study: PubMed 30247752Jung JW, Ha DH, Kim BY, Seo BF, Han HH, Kim DH, Rhie JW, Kim SW, Cho DW. Nasal Reconstruction Using a Customized Three-Dimensional-Printed Stent for Congenital Arhinia: Three-Year Follow-up. Laryngoscope. 2019 Mar;129(3):582-585. doi: 10.1002/lary.27335. Epub 2018 Sep 24.
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Arhinia, run by Seoul St. Mary's Hospital.
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 4 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 24 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
Nasal cavity diameter (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02559050, which also lists 1 linked publication.
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 24 Sep 2015.