Clinical Effect of a Nasal Former in Nasal Deformities

NCT ID: NCT02348931

Last Updated: 2015-01-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-12-31

Study Completion Date

2015-12-31

Brief Summary

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Investigation of the effect of customized nasal braces in the correction of nasal deformities with and without prior corrective surgery.

* Trial with medicinal product

Detailed Description

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Conditions

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Nose Deformity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Use of customized nasal brace (Nasella) for nose deformities

Intervention Type DEVICE

corrective surgery

Intervention Type PROCEDURE

Surgery, no device thereafter

Person in need of surgery has cast for 1 week; thereafter no use of customized nasal brace (Nasella) .

Group Type EXPERIMENTAL

corrective surgery

Intervention Type PROCEDURE

Only device (Nasella)

No need for surgery; use of customized nasal brace (Nasella) for nose deformities is made to improve look (cosmetic reason).

Group Type ACTIVE_COMPARATOR

Use of customized nasal brace (Nasella) for nose deformities

Intervention Type DEVICE

Interventions

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Use of customized nasal brace (Nasella) for nose deformities

Intervention Type DEVICE

corrective surgery

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Zurich

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Thomas N Roth, Dr. med.

Role: PRINCIPAL_INVESTIGATOR

University Hospital Zurich, Department of Otorhinolaryngology

Locations

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University Hospital Zurich, Department of Otorhinolaryngology

Zurich, Canton of Zurich, Switzerland

Site Status RECRUITING

Countries

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Switzerland

Central Contacts

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Silva Stutz, MSc

Role: CONTACT

+41 (0)44 255 11 11

Thomas N Roth, Dr. med.

Role: CONTACT

Facility Contacts

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Thomas Roth, Dr. med.

Role: primary

+41 44 255 11 11

Other Identifiers

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2013-0021

Identifier Type: OTHER

Identifier Source: secondary_id

RT_12_05_2013

Identifier Type: -

Identifier Source: org_study_id

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