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Validity Study of a Nasal Valve Implant

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00837525
Recruitment Status : Unknown
Verified February 2009 by Nasoform, LLC.
Recruitment status was:  Enrolling by invitation
First Posted : February 5, 2009
Last Update Posted : February 5, 2009
Sponsor:
Information provided by:

February 4, 2009
February 5, 2009
February 5, 2009
February 2009
May 2010   (Final data collection date for primary outcome measure)
Nasal obstruction symptom scale [ Time Frame: 1 year ]
Same as current
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
Validity Study of a Nasal Valve Implant
Validity of Biodegradable Injectable Implant for the Treatment of External Nasal Valve Collapse.
The purpose of this study is to determine if an implant material can be injected to repair nasal valve collapse.
Not Provided
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Nasal Valve Collapse
Procedure: nasal valve implant
Injectable implantation of a biodegradable material for support of the Nasal valve.
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
4
June 2010
May 2010   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Has nasal valve collapse

Exclusion Criteria:

  • Pregnancy
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00837525
NVB
No
Not Provided
Not Provided
Iyad Saidi, Nasoform
Nasoform, LLC
Not Provided
Principal Investigator: Iyad S Saidi, MD PhD Metropolitan ENT and Facial Plastic Surgery
Nasoform, LLC
February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP