NCT02559050

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2013

Shorter than P25 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2013

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

August 26, 2015

Completed
29 days until next milestone

First Posted

Study publicly available on registry

September 24, 2015

Completed
Last Updated

September 24, 2015

Status Verified

September 1, 2015

Enrollment Period

7 months

First QC Date

August 26, 2015

Last Update Submit

September 23, 2015

Conditions

Outcome Measures

Primary Outcomes (1)

  • Nasal cavity diameter

    Change from baseline nasal cavity diameter (measured by CT sagittal section, in millimeters)

    6 months

Interventions

Silicone stent with unconventional shape, 3D-printed based on patient's computed topographical images, to exactly fit newly made nasal cavity.

Eligibility Criteria

Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

A 7-year-old male patient with congenital arhinia with no history of previous treatment.

You may qualify if:

  • Single patient
  • year-old male
  • Congenital arhinia
  • No history of previous treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Arrhinia

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 26, 2015

First Posted

September 24, 2015

Study Start

May 1, 2013

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

September 24, 2015

Record last verified: 2015-09