CompletedNot Applicable

EFS of Bioabsorbable Implant for NSD

United States21 participantsStarted 2022-05-25

Plain-language summary

Early feasibility study of bioabsorbable implant and delivery device for correction of septal deviation

Who can participate

Age range

21 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: * Non-calcified, mobile cartilaginous septal deviation. * ≥21 years of age. * Willing and able to provide informed consent and comply with the study protocol. * Seeking treatment for nasal airway obstruction (NAO) due to septal deviation and is willing to undergo a nasal implant procedure. * Type I, II, or III septal deviation as defined by 7-Degree Mladina classification scheme * NOSE score ≥30 at Screening Visit. * Appropriate nasal anatomy to receive the implant(s). Exclusion Criteria: * Type IV, V, VI or VII septal deviation as defined by 7-Degree Mladina classification scheme (See Table 2) or other non-cartilaginous septum anatomical pathology identified on CT scan suspected by Investigator to be the primary contributor to NAO. * Having a concurrent ENT procedure, other than turbinate reduction. * Previous septoplasty or rhinoplasty. * Has had turbinate reduction or other nasal surgeries within the past six (6) months. * Plans to have any surgical or non-surgical treatment of their nasal septum, other than the index procedure, within six (6) months of the procedure. * Permanent implant or dilator in the nasal area. * Concomitant autoimmune, inflammatory, or infectious skin conditions, unhealed wounds, septal perforation, or mucosal irregularities in the treatment area. * Currently has active nasal vestibulitis or folliculitis. * History of nasal vasculitis. * Current or chronic systemic steroid and/or recreational intra-nasal drug user. * Has had a…

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

Number of participants with successful implantation as measured through physician's assessment and patient reported outcomes

Timeframe: 24 months

Trial details

NCT IDNCT05967169

SponsorSpirair, Inc

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-10-16

View on ClinicalTrials.gov More Nasal Septal Deviation trials

Who can participate

Age range

21 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.