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. 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
Information provided by:
Nasoform, LLC

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

Condition or disease Intervention/treatment Phase
Nasal Valve Collapse Procedure: nasal valve implant Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 4 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Validity of Biodegradable Injectable Implant for the Treatment of External Nasal Valve Collapse.
Study Start Date : February 2009
Estimated Primary Completion Date : May 2010
Estimated Study Completion Date : June 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shock
U.S. FDA Resources

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

Primary Outcome Measures :
  1. Nasal obstruction symptom scale [ Time Frame: 1 year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Has nasal valve collapse

Exclusion Criteria:

  • Pregnancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00837525

United States, Virginia
Metropolitan ENT and Facial Plastic Surgery
Alexandria, Virginia, United States, 22310
Sponsors and Collaborators
Nasoform, LLC
Principal Investigator: Iyad S Saidi, MD PhD Metropolitan ENT and Facial Plastic Surgery

Responsible Party: Iyad Saidi, Nasoform Identifier: NCT00837525     History of Changes
Other Study ID Numbers: NVB
First Posted: February 5, 2009    Key Record Dates
Last Update Posted: February 5, 2009
Last Verified: February 2009

Additional relevant MeSH terms:
Pathologic Processes