Study of Polyester Implants for the Treatment of External Nasal Valve Collapse (NVC) (NCT00729781) | Clinical Trial Compass
TerminatedPhase 1/2
Study of Polyester Implants for the Treatment of External Nasal Valve Collapse (NVC)
Stopped: Strategic Business Decision
United States45 participantsStarted 2008-04
Plain-language 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 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* 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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Functional Improvement
Timeframe: 12 weeks after implantation
2
Cosmetic Improvement
Timeframe: 12 weeks after implantation
3
Safety
Timeframe: During 12-week original study and at long-term follow-up of 11 months or longer