Dissolvable nose implant shows promise for easier breathing
NCT ID NCT05967169
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
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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
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21 people
The number who actually took part.
- Started
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May 2022
- Finished
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Mar 2026
- Lead sponsor
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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
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21 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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
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Breathe Clear Institute
Torrance, California, 90503, United States
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Specialty Physicians
Bethlehem, Pennsylvania, 18017, United States
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