Clinical Effect of a Nasal Former in Nasal Deformities

University of Zurich (UZH)

Status and phase: Unknown; Phase 3

Conditions: Nose Deformity

Treatments: Procedure: corrective surgery; Device: Use of customized nasal brace (Nasella) for nose deformities

Study type: Interventional

Funder types: Other

Identifiers

NCT02348931

RT_12_05_2013

2013-0021 (Other Identifier)

Details and patient eligibility

About

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

• Trial with medicinal product

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 3 patient groups

Surgery plus device (Nasella)

Active Comparator group

Description:

Person in need of surgery has cast for one week, then use of customized nasal brace for nose (Nasella) deformities during 8 weeks.

Treatment:

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

Procedure: corrective surgery

Surgery, no device thereafter

Experimental group

Description:

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

Treatment:

Procedure: corrective surgery

Only device (Nasella)

Active Comparator group

Description:

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

Treatment:

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