Clinical Effect of a Nasal Former in Nasal Deformities

Study Overview
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Brief Summary
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Investigation of the effect of customized nasal braces in the correction of nasal deformities with and without prior corrective surgery. Trial with medicinal product

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

Conditions
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Nose Deformity

Intervention / Treatment
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* Device: Use of customized nasal brace (Nasella) for nose deformities
* Procedure: corrective surgery


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Surgery plus device (Nasella)<br>Person in need of surgery has cast for one week, then use of customized nasal brace for nose (Nasella) deformities during 8 weeks. | Device: Use of customized nasal brace (Nasella) for nose deformities<br> <br> Procedure: corrective surgery<br> <br> |
| Experimental: Surgery, no device thereafter<br>Person in need of surgery has cast for 1 week; thereafter no use of customized nasal brace (Nasella) . | Procedure: corrective surgery<br> <br> |
| Active Comparator: Only device (Nasella)<br>No need for surgery; use of customized nasal brace (Nasella) for nose deformities is made to improve look (cosmetic reason). | Device: Use of customized nasal brace (Nasella) for nose deformities<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective Satisfaction |  | 9 weeks postoperatively | 
| Subjective Satisfaction |  | 14 months of treatment | 
| Doctors assessment of various appearances |  | 9 weeks postoperatively | 
| Doctors assessment of various appearances |  | 14 months after treatment |