Nose Deformity Clinical Trial
Official title:
Investigation of the Effect of a Customized Nasal Brace on Nasal Deformities With or Without Prior Surgery
Investigation of the effect of customized nasal braces in the correction of nasal
deformities with and without prior corrective surgery.
- Trial with medicinal product
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Switzerland | University Hospital Zurich, Department of Otorhinolaryngology | Zurich | ZH |
Lead Sponsor | Collaborator |
---|---|
University of Zurich |
Switzerland,
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 |
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