Open-Label Study to Evaluate the Safety and Effectiveness of the Spirair Implant (NCT06163404) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Open-Label Study to Evaluate the Safety and Effectiveness of the Spirair Implant
United States102 participantsStarted 2023-11-01
Plain-language summary
Pilot study of bioabsorbable implant and delivery device for correction of septal deviation.
Who can participate
Age range
21 Years – 70 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:
* ≥21 to ≤ 70 years of age at time of consent
* Seeking treatment for nasal airway obstruction (NAO) symptoms due primarily to cartilaginous nasal septal deviation
* Willing to undergo a nasal implant procedure
* NOSE score ≥30 at Baseline Visit
* Non-calcified, mobile cartilaginous nasal septal deviation
Exclusion Criteria:
* Target nasal septal deviation that is calcified or non-mobile
* Previous septoplasty or rhinoplasty
* Having a concurrent ENT procedure, other than turbinate reduction
* Saddle nose deformity
* Congenital nasal defect
* Documented evidence that middle meatus is not visualized on endoscopic exam due to severe septal deviation
* Turbinate reduction within the past six (6) months
* Permanent implant or dilator in the nose
* History of nasal vasculitis, unhealed wounds, cartilaginous nasal septal perforation or mucosal irregularities
* Active infection at the impllantation site e.g., folliculitis
* Current or chronic systemic steroid and/or has had radiation exposure or active chemotherapy in the treatment area
* Polyps or pathology, other than turbinate hypertrophy, that may be primary contributor to airway obstruction, in the opinion of the Investigator
* History of a significant bleeding disorder(s) and or taking current prescription blood thinner medication
* Hypersensitivity to any investigational device materials inclusing known or suspected allergy to poly(dioxanone) (PDO) or other bioabsorbable materials
* Major medical condit…
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.