Clinical Effect of a Nasal Former in Nasal Deformities

Nose Deformity Clinical Trial

Official title:

Investigation of the Effect of a Customized Nasal Brace on Nasal Deformities With or Without Prior Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02348931
• Other study ID #: RT_12_05_2013
• Secondary ID: 2013-0021
• Status: Recruiting
• Phase: Phase 3
• First received: March 21, 2014
• Last updated: January 27, 2015
• Start date: December 2013
• Est. completion date: December 2015

Study information

• Verified date: January 2015
• Source: University of Zurich
• Contact: Silva Stutz, MSc
• Phone: +41 (0)44 255 11 11
• Email: silva.stutz[@]usz.ch
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Interventional

Clinical Trial Summary

Investigation of the effect of customized nasal braces in the correction of nasal deformities with and without prior corrective surgery.

• Trial with medicinal product

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion criteria:

• Healthy adults with skewed, humped or broad nose, who are able to attend all follow-ups

Exclusion criteria:

• Inability to keep the research plan

• Allergies to components of the nasal brace

• Diseases of the bone metabolism

• Medication affecting bone metabolism

• Drugs or alcohol abuse

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Congenital Abnormalities
• Nose Deformity

Intervention

Device:
• Use of customized nasal brace (Nasella) for nose deformities

Procedure:
• corrective surgery

Locations

Country	Name	City	State
Switzerland	University Hospital Zurich, Department of Otorhinolaryngology	Zurich	ZH

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Skewed nose: Deviation from the 0° axis in the coronar plain (Philtrum-Glabella line).	The deviation from a perfect line (0 axis) is measured and compared to control group	9 Weeks after surgery	No
Primary	Humped nose: Deviation from the 0° axis in the sagittal plain (line from nose root to tip).	The deviation from a perfect line (0 axis) is measured and compared to control group	9 Weeks after surgery	No
Primary	Broad nose: Appealing proportion of nose width to eye-corner distance.	The deviation from a perfect line (0 axis) is measured and compared to control group	9 weeks after surgery	No
Primary	Skewed nose: Deviation from the 0° axis in the coronar plain (Philtrum-Glabella line).	The improvement in degrees compared to study start	14 months of treatment with Nasella	No
Primary	Humped nose: Deviation from the 0° axis in the sagittal plain (line from nose root to tip).	The improvement in degrees compared to study start	14 months of treatment with Nasella	No
Primary	Broad nose: Appealing proportion of nose width to eye-corner distance.	The improvement of proportion of width compare to study start	14 months of treatment with Nasella	No
Secondary	Subjective Satisfaction		9 weeks postoperatively	No
Secondary	Subjective Satisfaction		14 months of treatment	No
Secondary	Doctors assessment of various appearances		9 weeks postoperatively	No
Secondary	Doctors assessment of various appearances		14 months after treatment	No