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Dissolvable nose implant shows promise for easier breathing

NCT ID NCT05967169

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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early study tested a new dissolvable implant designed to straighten the cartilage inside the nose in people with a deviated septum. Twenty-one adults with nasal blockage received the implant in a quick procedure. The main goal was to see if the implant could be placed safely and stay in place during healing. Results suggest the approach is feasible, but larger and longer studies are needed to know if it truly improves breathing long-term.

What this could mean

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

Active substance
bioabsorbable polydioxanone implant (Nasal Septal Strap)
What this could lead to
If it works, this could offer a less invasive, temporary option to improve breathing in people with a deviated septum, avoiding more complex surgery.
What could go wrong
This was a very small early study with only 21 people and no comparison group. The implant is temporary and may not work for everyone, especially those with calcified or severe deviations.

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

21 people

The number who actually took part.

Started

May 2022

Finished

Mar 2026

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 years and older

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: * 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 cancerous or pre-cancerous lesion and/or has had radiation exposure in the treatment area or active chemotherapy. * 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 current prescription blood thinner medication that would prevent healing of the treatment area post procedure. * Known or suspected allergy to polydioxanone or other absorbable materials. * Significant systemic disease such as poorly controlled diabetes or connective tissue disease which, in the investigator's opinion, could pre-dispose the participant to poor wound healing. * Current tobacco or tobacco-related product use or history within the past 10 years of heavy smoking (on average, more than half a pack of cigarettes per day). * Female participants of childbearing potential who are known or suspected to be pregnant and/or lactating. * Any physical condition that, in the Investigator's opinion, would prevent adequate study participation or increase risk. * Additionally, for OR cases (Cohorts 1 or 3) any individual who meets the following criteria will be ineligible for enrollment as an OR case * Is not a candidate for procedures conducted under general anesthesia. * Additionally, for in-office cases (Cohort 2) any individual who meets the following criteria will be ineligible for enrollment as an in-office case: * s not a candidate for procedures conducted under local anesthesia alone.

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As listed by the trial registrant

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

Contacts and locations

Locations

  • Breathe Clear Institute

    Torrance, California, 90503, United States

  • Specialty Physicians

    Bethlehem, Pennsylvania, 18017, United States

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