Clinical Effect of a Nasal Former in Nasal Deformities

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

Study Overview

• Status: Unknown
• Conditions: Nose Deformity
• Intervention / Treatment: Device: Use of customized nasal brace (Nasella) for nose deformities; Procedure: corrective surgery

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Phase 3

Contacts and Locations

Study Locations

• Switzerland
  • ZH
    • Zurich, ZH, Switzerland, 8091
      • Recruiting
      • University Hospital Zurich, Department of Otorhinolaryngology
      • Contact: Thomas Roth, Dr. med.; Phone Number: +41 44 255 11 11
      • Principal Investigator: Thomas Roth, Dr. med.
      • Sub-Investigator: Michael Soyka, Dr. med.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Surgery plus device (Nasella); 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; Procedure: corrective surgery
Experimental: Surgery, no device thereafter; Person in need of surgery has cast for 1 week; thereafter no use of customized nasal brace (Nasella) .	Procedure: corrective surgery
Active Comparator: Only device (Nasella); 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

What is the study measuring?

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	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

Collaborators and Investigators

• Sponsor: University of Zurich
• Investigators: Principal Investigator: Thomas N Roth, Dr. med., University Hospital Zurich, Department of Otorhinolaryngology

Study record dates

Study Major Dates

• Study Start: December 1, 2013
• Primary Completion (Anticipated): December 1, 2015
• Study Completion (Anticipated): December 1, 2015

Study Registration Dates

• First Submitted: March 21, 2014
• First Submitted That Met QC Criteria: January 27, 2015
• First Posted (Estimate): January 28, 2015

Study Record Updates

• Last Update Posted (Estimate): January 28, 2015
• Last Update Submitted That Met QC Criteria: January 27, 2015
• Last Verified: January 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Congenital Abnormalities
• Other Study ID Numbers: RT_12_05_2013; 2013-0021 (Other Identifier: Ethics Commission of Zurich)