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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
  Purpose

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


Condition Intervention
Nasal Valve Collapse
 Procedure: nasal valve implant

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Validity of Biodegradable Injectable Implant for the Treatment of External Nasal Valve Collapse.

Resource links provided by NLM:

MedlinePlus related topics: Shock
U.S. FDA Resources

Further study details as provided by Nasoform, LLC:

Primary Outcome Measures:
  • Nasal obstruction symptom scale [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 4
Study Start Date: February 2009
Estimated Study Completion Date: June 2010
Estimated Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: nasal valve implant
    Injectable implantation of a biodegradable material for support of the Nasal valve.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Has nasal valve collapse

Exclusion Criteria:

  • Pregnancy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00837525

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

No publications provided

Responsible Party: Iyad Saidi, Nasoform
ClinicalTrials.gov Identifier: NCT00837525     History of Changes
Other Study ID Numbers: NVB
Study First Received: February 4, 2009
Last Updated: February 4, 2009
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Shock
Pathologic Processes

ClinicalTrials.gov processed this record on May 16, 2013