Back to resultsValidity Study of a Nasal Valve Implant
Primary Purpose
Nasal Valve Collapse
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
nasal valve implant
Sponsored by
About this trial
This is an interventional treatment trial for Nasal Valve Collapse
Eligibility Criteria
Inclusion Criteria:
- Has nasal valve collapse
Exclusion Criteria:
- Pregnancy
Sites / Locations
- Metropolitan ENT and Facial Plastic Surgery
Outcomes
Primary Outcome Measures
Nasal obstruction symptom scale
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00837525
Brief Title
Validity Study of a Nasal Valve Implant
Official Title
Validity of Biodegradable Injectable Implant for the Treatment of External Nasal Valve Collapse.
Study Type
Interventional
2. Study Status
Record Verification Date
February 2009
Overall Recruitment Status
Unknown status
Study Start Date
February 2009 (undefined)
Primary Completion Date
May 2010 (Anticipated)
Study Completion Date
June 2010 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Nasoform, LLC
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to determine if an implant material can be injected to repair nasal valve collapse.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nasal Valve Collapse
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
4 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
nasal valve implant
Intervention Description
Injectable implantation of a biodegradable material for support of the Nasal valve.
Primary Outcome Measure Information:
Title
Nasal obstruction symptom scale
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Has nasal valve collapse
Exclusion Criteria:
Pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Iyad S Saidi, MD PhD
Organizational Affiliation
Metropolitan ENT and Facial Plastic Surgery
Official's Role
Principal Investigator
Facility Information:
Facility Name
Metropolitan ENT and Facial Plastic Surgery
City
Alexandria
State/Province
Virginia
ZIP/Postal Code
22310
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Validity Study of a Nasal Valve Implant
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