Status:
TERMINATED
Study of Polyester Implants for the Treatment of External Nasal Valve Collapse (NVC)
Lead Sponsor:
Medtronic Xomed, Inc.
Collaborating Sponsors:
Medtronic
Conditions:
Nasal Alar Collapse, Bilateral
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of this study is to research a polyester polyethylene terephthalate (PET) implant for the treatment of external nasal valve collapse (NVC). NVC is a condition which causes narrowness and w...
Detailed Description
The effects of PET implants on external NVC and cosmetic contour deformity will be evaluated in an open-label, prospective study. Subjects for this clinical study will be recruited and screened from c...
Eligibility Criteria
Inclusion
- Is willing and able to sign an informed consent form
- Is 18 years of age or older
- Has positive response to any of the following based on patient history or office exam:
- Use of Breath Rite Strips
- Q-Tip test
- Use of Nasal stents
- Continuous manual distraction
- Has inspiratory lateral nasal wall collapse or static medially obstructing lateral nasal wall position identified on physical exam
- Has nasal valve that is narrow (either static or dynamic) based on a visual examination.
- Has nasal septum that is considered stable and adequate to support the treatment of each nasal valve independently.
- Is motivated and willing to comply with study and its follow-up requirements, including surgical intervention using the Pillar implant system for the treatment of nasal valve collapse
- Speaks English
- Has unilateral or bilateral nasal valve collapse
Exclusion
- Has ability to achieve active nostril dilation and relieve obstruction using physiologic nasal alar and sidewall muscle actions
- Has chronic sinusitis, recurrent sinusitis, or allergies leading to nasal obstruction.
- Has active nasal infection
- Has skin inflammation in the nasal area
- Is a habitual chronic sniffer
- Has septal deviation, turbinate hypertrophy, polyps, or ptotic nose tip believed to be causing obstruction
- Has had previous rhinoplasty of external nasal frame
- Requires another surgery other than implants to correct an obstruction
- Has nasal anatomy that is inadequate to accommodate three 18 mm implants
- Is participating in a clinical study for another treatment for nasal valve collapse
- Is pregnant or desires to become pregnant during the duration of the study
- Has a history of drug abuse or alcoholism in the year before enrollment
- Has had previous surgery for external nasal valve collapse
- Has an American Society of Anesthesiologists (ASA) rating of III or IV
- Has any other condition believed to interfere with nasal assessments
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2011
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT00729781
Start Date
April 1 2008
End Date
January 1 2011
Last Update
January 6 2012
Active Locations (5)
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1
UC Davis Medical Center
Sacramento, California, United States, 95817-2207
2
Premier Image Cosmetic & Laser
Atlanta, Georgia, United States, 30338-6408
3
DuPage Medical Group, Ltd
Downers Grove, Illinois, United States, 60515
4
Ear, Nose, & Throat Physicians
Sterling Heights, Michigan, United States, 48314