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Clinical Trials/NCT02348931
NCT02348931
Unknown
Phase 3

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

University of Zurich1 site in 1 country100 target enrollmentDecember 2013
ConditionsNose Deformity

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Nose Deformity
Sponsor
University of Zurich
Enrollment
100
Locations
1
Primary Endpoint
Broad nose: Appealing proportion of nose width to eye-corner distance.
Last Updated
11 years ago

Overview

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
Registry
clinicaltrials.gov
Start Date
December 2013
End Date
December 2015
Last Updated
11 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Broad nose: Appealing proportion of nose width to eye-corner distance.

Time Frame: 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).

Time Frame: 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).

Time Frame: 14 months of treatment with Nasella

The improvement in degrees compared to study start

Secondary Outcomes

  • Doctors assessment of various appearances(14 months after treatment)
  • Subjective Satisfaction(14 months of treatment)

Study Sites (1)

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