Back to resultsClinical Effect of a Nasal Former in Nasal Deformities
Primary Purpose
Nose Deformity
Status
Unknown status
Phase
Phase 3
Locations
Switzerland
Study Type
Interventional
Intervention
Use of customized nasal brace (Nasella) for nose deformities
corrective surgery
Sponsored by
About this trial
This is an interventional treatment trial for Nose Deformity
Eligibility Criteria
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
Sites / Locations
- University Hospital Zurich, Department of OtorhinolaryngologyRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
Active Comparator
Arm Label
Surgery plus device (Nasella)
Surgery, no device thereafter
Only device (Nasella)
Arm Description
Person in need of surgery has cast for one week, then use of customized nasal brace for nose (Nasella) deformities during 8 weeks.
Person in need of surgery has cast for 1 week; thereafter no use of customized nasal brace (Nasella) .
No need for surgery; use of customized nasal brace (Nasella) for nose deformities is made to improve look (cosmetic reason).
Outcomes
Primary Outcome Measures
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
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
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
Skewed nose: Deviation from the 0° axis in the coronar plain (Philtrum-Glabella line).
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).
The improvement in degrees compared to study start
Broad nose: Appealing proportion of nose width to eye-corner distance.
The improvement of proportion of width compare to study start
Secondary Outcome Measures
Subjective Satisfaction
Subjective Satisfaction
Doctors assessment of various appearances
Doctors assessment of various appearances
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02348931
Brief Title
Clinical Effect of a Nasal Former in Nasal Deformities
Official Title
Investigation of the Effect of a Customized Nasal Brace on Nasal Deformities With or Without Prior Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
January 2015
Overall Recruitment Status
Unknown status
Study Start Date
December 2013 (undefined)
Primary Completion Date
December 2015 (Anticipated)
Study Completion Date
December 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Zurich
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nose Deformity
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Surgery plus device (Nasella)
Arm Type
Active Comparator
Arm Description
Person in need of surgery has cast for one week, then use of customized nasal brace for nose (Nasella) deformities during 8 weeks.
Arm Title
Surgery, no device thereafter
Arm Type
Experimental
Arm Description
Person in need of surgery has cast for 1 week; thereafter no use of customized nasal brace (Nasella) .
Arm Title
Only device (Nasella)
Arm Type
Active Comparator
Arm Description
No need for surgery; use of customized nasal brace (Nasella) for nose deformities is made to improve look (cosmetic reason).
Intervention Type
Device
Intervention Name(s)
Use of customized nasal brace (Nasella) for nose deformities
Intervention Type
Procedure
Intervention Name(s)
corrective surgery
Primary Outcome Measure Information:
Title
Skewed nose: Deviation from the 0° axis in the coronar plain (Philtrum-Glabella line).
Description
The deviation from a perfect line (0 axis) is measured and compared to control group
Time Frame
9 Weeks after surgery
Title
Humped nose: Deviation from the 0° axis in the sagittal plain (line from nose root to tip).
Description
The deviation from a perfect line (0 axis) is measured and compared to control group
Time Frame
9 Weeks after surgery
Title
Broad nose: Appealing proportion of nose width to eye-corner distance.
Description
The deviation from a perfect line (0 axis) is measured and compared to control group
Time Frame
9 weeks after surgery
Title
Skewed nose: Deviation from the 0° axis in the coronar plain (Philtrum-Glabella line).
Description
The improvement in degrees compared to study start
Time Frame
14 months of treatment with Nasella
Title
Humped nose: Deviation from the 0° axis in the sagittal plain (line from nose root to tip).
Description
The improvement in degrees compared to study start
Time Frame
14 months of treatment with Nasella
Title
Broad nose: Appealing proportion of nose width to eye-corner distance.
Description
The improvement of proportion of width compare to study start
Time Frame
14 months of treatment with Nasella
Secondary Outcome Measure Information:
Title
Subjective Satisfaction
Time Frame
9 weeks postoperatively
Title
Subjective Satisfaction
Time Frame
14 months of treatment
Title
Doctors assessment of various appearances
Time Frame
9 weeks postoperatively
Title
Doctors assessment of various appearances
Time Frame
14 months after treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Silva Stutz, MSc
Phone
+41 (0)44 255 11 11
Email
silva.stutz@usz.ch
First Name & Middle Initial & Last Name or Official Title & Degree
Thomas N Roth, Dr. med.
Email
thomas.roth@usz.ch
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas N Roth, Dr. med.
Organizational Affiliation
University Hospital Zurich, Department of Otorhinolaryngology
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Zurich, Department of Otorhinolaryngology
City
Zurich
State/Province
ZH
ZIP/Postal Code
8091
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thomas Roth, Dr. med.
Phone
+41 44 255 11 11
First Name & Middle Initial & Last Name & Degree
Thomas Roth, Dr. med.
First Name & Middle Initial & Last Name & Degree
Michael Soyka, Dr. med.
12. IPD Sharing Statement
Learn more about this trial
Clinical Effect of a Nasal Former in Nasal Deformities
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