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New bioabsorbable implant aims to fix deviated septum without surgery

NCT ID NCT06163404

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study is testing a new device called the Spirair implant, which is placed inside the nose to straighten a crooked nasal septum (the wall between the nostrils). The goal is to improve breathing in people with nasal airway obstruction. About 102 adults aged 21 to 70 who have not had prior nose surgery are participating. The implant is designed to dissolve over time after helping the cartilage stay in the correct position.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Spirair bioabsorbable implant (SeptAlign) and delivery system
What this could lead to
If successful, this could offer a less invasive alternative to traditional septoplasty for people with nasal airway obstruction due to a deviated septum.
What could go wrong
This is a small, early pilot study (102 participants) with no control group. The implant may not provide lasting improvement, and there are risks of serious device-related side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

102 people

The number who actually took part.

Started

Nov 2023

Expected to finish

Jun 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

21 to 70 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 condition that could affect quality of life or wound healing and influence the results of the study (e.g., poorly controlled diabetes, HIV or other immunosuppressive conditions, active malignancy in the past 5 years, acute MI, CVA, etc.) * Active smoker or history of tobacco or tobacco-related product use within the past 1 year * Documented evidence of a history (e.g., liver testing) of drug/alcohol abuse within 12 months of enrollment * Females of child-bearing potential who are either pregnant or breastfeeding or plan to become pregnant during the course of the study * Currently participating, or plans to enroll in another clinical trial during this study or undergo another nasal septal treatment during study participation * History of non-compliance with medical treatment or clinical trial participation * Subject is physically or mentally compromised (e.g., currently being treated for a psychiatric disorder, senile dementia, Alzheimer's disease, etc.), to the extent that the Investigator determines the subject to be unable or unlikely to comply with protocol required follow-up * Any comorbidity or condition that renders the patient a poor surgical candidate as determined by the Investigator * The subject is receiving prescription narcotic pain medication * The subject's condition represents a worker's compensation case * Symptoms of an upper respiratory infection e.g., runny nose, sneezing * History of untreated or inadequately controlled rhinitis (allergic and/or nonallergic)

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Conditions

The condition(s) this trial relates to.

Nasal Obstruction

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Alabama Nasal and Sinus Center

    Birmingham, Alabama, 35242, United States

  • Albany ENT & Allergy Services, PC

    Albany, New York, 12205, United States

  • Breathe Clear Institute

    Torrance, California, 90503, United States

  • Ear Nose Throat & Allergy Associates

    Puyallup, Washington, 98374, United States

  • Kentuckiana Ear, Nose & Throat

    Louisville, Kentucky, 40241, United States

  • Sinus and Nasal Specialists of LA

    Baton Rouge, Louisiana, 70809, United States

  • Specialty Physicians

    Bethlehem, Pennsylvania, 18017, United States

  • Tandem Clinical Research

    Marrero, Louisiana, 70072, United States

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