Nose DeformityPhase 3NCT02348931
Clinical Effect of a Nasal Former in Nasal Deformities
A Phase 3 study testing Use of customized nasal brace (Nasella) for nose deformities and corrective surgery in people with Nose Deformity, run by University of Zurich at 1 site in Switzerland.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nose Deformity
- What is being tested?
- Use of customized nasal brace (Nasella) for nose deformities and corrective surgery
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSwitzerland
- Study dates
- Dec 2013to Dec 2015
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Healthy adults with skewed, humped or broad nose, who are able to attend all follow-ups
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Thomas N Roth, Dr. med. contact
Switzerland1 site, 1 recruiting
- Recruiting
University Hospital Zurich, Department of Otorhinolaryngology
Zurich, Canton of Zurich, 8091
Thomas Roth, Dr. med., +41 44 255 11 11
Thomas Roth, Dr. med.
About this study
Official title: 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
- Conditions
- Nose Deformity
- Being tested
- Use of customized nasal brace (Nasella) for nose deformities, corrective surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Use of customized nasal brace (Nasella) for nose deformitiesDevice
corrective surgeryProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Surgery plus device (Nasella) | Active comparator | Person in need of surgery has cast for one week, then use of customized nasal brace for nose (Nasella) deformities during 8 weeks. Receives: Device: Use of customized nasal brace (Nasella) for nose deformities; Procedure: corrective surgery |
| Surgery, no device thereafter | Experimental | Person in need of surgery has cast for 1 week; thereafter no use of customized nasal brace (Nasella) . Receives: Procedure: corrective surgery |
| Only device (Nasella) | Active comparator | No need for surgery; use of customized nasal brace (Nasella) for nose deformities is made to improve look (cosmetic reason). Receives: Device: Use of customized nasal brace (Nasella) for nose deformities |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 14 months of treatment with Nasella
Secondary outcomes (4)
Subjective Satisfaction
Measured: 9 weeks postoperatively
Subjective Satisfaction
Measured: 14 months of treatment
Doctors assessment of various appearances
Measured: 9 weeks postoperatively
Doctors assessment of various appearances
Measured: 14 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2015 (estimated)
- Study startDec 2013
- Primary completionDec 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nose DeformityStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thomas N Roth, Dr. med., Principal investigator, University Hospital Zurich, Department of Otorhinolaryngology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02348931
- Sponsor's protocol ID
- RT_12_05_2013
- Other IDs
- 2013-0021
- Status last verified
- Jan 2015
- First submitted
- 21 Mar 2014
- Last updated
- 28 Jan 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effect of a Customized Nasal Brace on Nasal Deformities With or Without Prior Surgery
- ClinicalTrials.gov ID
- NCT02348931
- Acronym / sponsor ID
- RT_12_05_2013
- Conditions
- Nose Deformity
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 28 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Surgery plus device (Nasella) | Active comparator | Device: Use of customized nasal brace (Nasella) for nose deformities, Procedure: corrective surgeryPerson 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 | Experimental | Procedure: corrective surgeryPerson in need of surgery has cast for 1 week; thereafter no use of customized nasal brace (Nasella) . |
| Only device (Nasella) | Active comparator | Device: Use of customized nasal brace (Nasella) for nose deformitiesNo need for surgery; use of customized nasal brace (Nasella) for nose deformities is made to improve look (cosmetic reason). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy adults with skewed, humped or broad nose, who are able to attend all follow-ups
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Use of customized nasal brace (Nasella) for nose deformities | Device | Only device (Nasella), Surgery plus device (Nasella) |
| corrective surgery | Procedure or surgery | Surgery plus device (Nasella), Surgery, no device thereafter |
Primary outcome
Skewed nose: Deviation from the 0° axis in the coronar plain (Philtrum-Glabella line).
Time frame: 9 Weeks after surgery
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).
Time frame: 9 Weeks after surgery
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.
Time frame: 9 weeks after surgery
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).
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
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
4 secondary outcomes
Subjective Satisfaction
Time frame: 9 weeks postoperatively
Subjective Satisfaction
Time frame: 14 months of treatment
Doctors assessment of various appearances
Time frame: 9 weeks postoperatively
Doctors assessment of various appearances
Time frame: 14 months after treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas N Roth, Dr. med. contact
Thomas N Roth, Dr. med. principal investigator
University Hospital Zurich, Department of Otorhinolaryngology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Use of customized nasal brace (Nasella) for nose deformities and corrective surgery in people with Nose Deformity, run by University of Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Silva Stutz, MSc (+41 (0)44 255 11 11, silva.stutz@usz.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Skewed nose: Deviation from the 0° axis in the coronar plain (Philtrum-Glabella line). (time frame: 9 Weeks after surgery). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2015.