Validity Study of a Nasal Valve Implant

Nasal Valve Collapse Clinical Trial

Official title:

Validity of Biodegradable Injectable Implant for the Treatment of External Nasal Valve Collapse.

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT00837525
• Other study ID #: NVB
• Status: Enrolling by invitation
• Phase: N/A
• First received: February 4, 2009
• Last updated: February 4, 2009
• Start date: February 2009
• Est. completion date: June 2010

Study information

• Verified date: February 2009
• Source: Nasoform, LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine if an implant material can be injected to repair nasal valve collapse.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 4
• Est. completion date: June 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Has nasal valve collapse

Exclusion Criteria:

• Pregnancy

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Nasal Valve Collapse
• Shock

Intervention

Procedure:
• nasal valve implant
Injectable implantation of a biodegradable material for support of the Nasal valve.

Locations

Country	Name	City	State
United States	Metropolitan ENT and Facial Plastic Surgery	Alexandria	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Nasoform, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Nasal obstruction symptom scale		1 year	No