Clinical Effect of a Nasal Former in Nasal Deformities

Phase 3

• Conditions: Nose Deformity
• Interventions: Device: Use of customized nasal brace (Nasella) for nose deformities; Procedure: corrective surgery

• Registration Number: NCT02348931
• Lead Sponsor: University of Zurich

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2013-12
• Study First Submitted: 2014-03-21
• Status Verified: 2015-01
• Study First Submitted QC: 2015-01-27
• Last Update Submitted: 2015-01-27
• Study First Posted: 2015-01-28
• Last Update Posted: 2015-01-28
• Primary Completion: 2015-12
• Study Completion: 2015-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Surgery plus device (Nasella)	corrective surgery	Person in need of surgery has cast for one week, then use of customized nasal brace for nose (Nasella) deformities during 8 weeks.
Surgery, no device thereafter	corrective surgery	Person in need of surgery has cast for 1 week; thereafter no use of customized nasal brace (Nasella) .
Surgery plus device (Nasella)	Use of customized nasal brace (Nasella) for nose deformities	Person in need of surgery has cast for one week, then use of customized nasal brace for nose (Nasella) deformities during 8 weeks.
Only device (Nasella)	Use of customized nasal brace (Nasella) for nose deformities	No need for surgery; use of customized nasal brace (Nasella) for nose deformities is made to improve look (cosmetic reason).

Primary Outcome Measures

Name	Time	Method
Broad nose: Appealing proportion of nose width to eye-corner distance.	14 months of treatment with Nasella	The improvement of proportion of width compare to study start
Skewed nose: Deviation from the 0° axis in the coronar plain (Philtrum-Glabella line).	14 months of treatment with Nasella	The improvement in degrees compared to study start
Humped nose: Deviation from the 0° axis in the sagittal plain (line from nose root to tip).	14 months of treatment with Nasella	The improvement in degrees compared to study start

Secondary Outcome Measures

Name	Time	Method
Doctors assessment of various appearances	14 months after treatment
Subjective Satisfaction	14 months of treatment

Trial Locations

Locations (1)

University Hospital Zurich, Department of Otorhinolaryngology; 🇨🇭 Zurich, ZH, Switzerland