Study of Polyester Implants for the Treatment of External Nasal Valve Collapse (NVC)

Stopped early · Phase 1/Phase 2

Conditions studied: Nasal Alar Collapse, Bilateral

In brief

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 weakness in the nostril which results in nasal obstruction. Implants will be placed in the affected nostril(s). The implants are intended to restore the shape and stabilize the nasal wall to prevent nasal valve collapse and improve the symptoms associated with nasal obstruction.

Key facts

Study ID

NCT00729781

Run by

Medtronic Xomed, Inc.

People needed

45

Starts

2008-04-01

Expected to finish

2011-01-01

Last updated by the study team

2012-01-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• UC Davis Medical Center — Sacramento, California, United States
• Premier Image Cosmetic & Laser — Atlanta, Georgia, United States
• DuPage Medical Group, Ltd — Downers Grove, Illinois, United States
• Ear, Nose, & Throat Physicians — Sterling Heights, Michigan, United States
• HealthPartners Specialty Clinic/Regions Hospital — Saint Paul, Minnesota, United States

Full record on ClinicalTrials.gov

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