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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 October 29, 2014