Validity Study of a Nasal Valve Implant

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
Nasoform, LLC
ClinicalTrials.gov Identifier:
NCT00837525
First received: February 4, 2009
Last updated: NA
Last verified: February 2009
History: No changes posted

February 4, 2009
February 4, 2009
February 2009
May 2010   (final data collection date for primary outcome measure)
Nasal obstruction symptom scale [ Time Frame: 1 year ] [ Designated as safety issue: No ]
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: 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.
 
Enrolling by invitation
4
June 2010
May 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Has nasal valve collapse

Exclusion Criteria:

  • Pregnancy
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00837525
NVB
No
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