NCT02348931

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Dec 2013

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2013

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 21, 2014

Completed
10 months until next milestone

First Posted

Study publicly available on registry

January 28, 2015

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

January 28, 2015

Status Verified

January 1, 2015

Enrollment Period

2 years

First QC Date

March 21, 2014

Last Update Submit

January 27, 2015

Conditions

Nose Deformity

Outcome Measures

Primary Outcomes (6)

  • 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 Outcomes (4)

  • 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

Study Arms (3)

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.

Device: Use of customized nasal brace (Nasella) for nose deformitiesProcedure: 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) .

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).

Device: Use of customized nasal brace (Nasella) for nose deformities

Interventions

Use of customized nasal brace (Nasella) for nose deformitiesDEVICE
Only device (Nasella)Surgery plus device (Nasella)
corrective surgeryPROCEDURE
Surgery plus device (Nasella)Surgery, no device thereafter

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy adults with skewed, humped or broad nose, who are able to attend all follow-ups

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Zurich, Department of Otorhinolaryngology

Zurich, Canton of Zurich, 8091, Switzerland

RECRUITING

Study Officials

  • Thomas N Roth, Dr. med.

    University Hospital Zurich, Department of Otorhinolaryngology

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Silva Stutz, MSc

CONTACT

+41 (0)44 255 11 11silva.stutz@usz.ch

Thomas N Roth, Dr. med.

CONTACT

thomas.roth@usz.ch

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 21, 2014

First Posted

January 28, 2015

Study Start

December 1, 2013

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

January 28, 2015

Record last verified: 2015-01

Locations

CH(1)