Spirair Implant for Deviated Septum

Recruiting at 10 trial locations

Overseen By Nora Perkins, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Spirair, Inc

Must not be taking: Blood thinners, Narcotic pain meds, Steroids

Disqualifiers: Calcified septal deviation, Previous septoplasty, Active smoker, Untreated rhinitis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 3 months

50 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a new device called the Spirair Implant, which helps straighten a crooked nasal septum. The implant is designed to be absorbed by the body over time. It aims to improve breathing and correct the shape of the septum in patients with this condition.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are on prescription blood thinners or narcotic pain medication. If you are taking these, you may need to stop before joining the trial.

What data supports the effectiveness of the Spirair Implant treatment for a deviated septum?

The research highlights the importance of straightening the nasal septum to achieve good functional and aesthetic results, which is relevant to the Spirair Implant treatment. Additionally, external nasal dilators, similar to the Spirair Nasal Device, are noted as a new treatment option for nasal obstruction, suggesting potential effectiveness in managing nasal septal deviation. ^{1 2 3 4 5}

What safety data exists for Spirair Implant for Deviated Septum?

A study on bioabsorbable nasal implants, similar to Spirair, found complications like abscesses and implant protrusion. Some patients experienced facial pain and issues with the implant not absorbing properly. Treatments included antibiotics, steroid injections, and sometimes removal of the implant. ^{2 6 7 8 9}

How is the Spirair Implant treatment for a deviated septum different from other treatments?

The Spirair Implant treatment is unique because it involves the implantation of a nasal device, which is different from traditional surgical methods that focus on reconstructing or repositioning the nasal septum. This approach may offer a less invasive option with potentially quicker recovery times compared to extensive surgery. ^{2 3 4 10 11}

Research Team

Brandon McCutcheon, MD

Principal Investigator

Spirair, CMO

Eligibility Criteria

Adults aged 21-64 with a deviated septum causing nasal blockage, who are seeking treatment and willing to undergo an implant procedure. Participants must have significant symptoms (NOSE score ≥30), speak English, and be able to follow the study protocol. Excluded are those with prior nose surgeries, concurrent ENT procedures other than turbinate reduction, certain nasal deformities or conditions, active infections at the site of implantation, recent drug abuse history, pregnant or breastfeeding women, and anyone unable to comply with the study requirements.

Inclusion Criteria

I am looking for treatment because my nose is blocked due to a bent nasal septum.

I am between 21 and 64 years old.

My nasal septum is bent without hardening and can move.

Exclusion Criteria

Hypersensitivity to any investigational device materials including known or suspected allergy to poly(dioxanone) (PDO) or other bioabsorbable materials

Documented evidence of a history (e.g., liver testing) of drug/alcohol abuse within 12 months of enrollment

History of non-compliance with medical treatment or clinical trial participation

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the Spirair Septal correction device and delivery system for correction of cartilaginous nasal septal deviation

3 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

9 months

Treatment Details

Interventions

• Implantation of Spirair Nasal Device

Trial Overview The trial is testing a new bioabsorbable Spirair Nasal Device implanted using a special delivery system designed for people with nasal airway obstruction due to septal deviation. It's an open-label pilot study which means everyone gets the device and knows what they're receiving.

Participant Groups

Group I: Investigational Device Experimental Treatment 1 Intervention

Treatment with the Spirair Septal correction device and delivery system for correction of cartilaginous nasal septal deviation.

Implantation of Spirair Nasal Device is already approved in United States for the following indications:

Approved in United States as SeptAlign for:

• Correction of minor cartilaginous septal deviation

Who Is Running the Clinical Trial?

Spirair, Inc

Lead Sponsor

Trials

2

Recruited

80+

Findings from Research

In a study of 10 non-apnoeic snorers, the Breathe Right (BR) device did not improve sleep quality or reduce snoring during two full-night sleep tests, indicating its ineffectiveness for this purpose.

Despite some participants having nasal valve anomalies, the presence of these anomalies did not affect the snoring index, further supporting the conclusion that BR does not alleviate snoring in non-apnoeic individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Breathe Right on snoring: a polysomnographic study. Liistro, G., Rombaux, P., Dury, M., et al.[2019]

A new technique for resecting upper and posterior nasal septum deviations using nasal endoscopy was evaluated in 109 patients, showing it to be safe and effective over a follow-up period of 1 to 50 months.

This method significantly improved nasal breathing and sense of smell while also reducing the risks of nasal cavity adhesions, recurrence of nasal polyps, and sinusitis, making it a promising option for clinicians.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The value of nasal endoscopy in the resection of upper and posterior nasal septum deviation]. You, X., Gao, Q., Liu, Z., et al.[2014]

Straightening the nasal septum is crucial for correcting severely deviated noses, and conservative management of the external nasal structure is emphasized to maintain support during the procedure.

When the septum is successfully modified and repositioned to the midline, it leads to consistently good functional and aesthetic outcomes, as demonstrated through various techniques and three case studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Management of the deviated nose. The importance of septal reconstruction. Gunter, JP., Rohrich, RJ.[2004]

A new surgical technique for correcting nasal deviation was successfully applied to 12 patients, with a follow-up period of 1 to 12 months, resulting in only one case of recurrence.

This method effectively allows for the removal of deformed septal cartilage while maintaining support for the nasal structure, preventing the cartilage from shifting back to its original position after surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Septorhinoplasty for nasal deviation complicated with septal cartilage deformity]. Li, D., Xie, H., You, W.[2006]

In a study of 76 children with nasal septal deviation, the use of external nasal dilators significantly improved symptoms of nasal obstruction compared to a control group that did not use the dilators.

However, the benefits of the external nasal dilators were not sustained after discontinuation, indicating that while they are effective for temporary relief, they may not be a long-term solution for patients not suitable for surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficiency of external nasal dilators in pediatric nasal septal deviation. Salturk, Z., Inan, M., Kumral, TL., et al.[2022]

A review of 26 reports on bioabsorbable nasal implants revealed that the most common complications were abscesses and implant protrusions, indicating potential safety concerns with these devices.

Management of adverse events often required interventions such as antibiotics, steroid injections, or even explantation, highlighting the need for further research to understand long-term complications and improve treatment protocols.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse Events Associated With Bioabsorbable Nasal Implants: A MAUDE Database Analysis. Wilkins, SG., Sheth, AH., Kayastha, D., et al.[2023]

The overall adverse event (AE) rate for nonsurgical rhinoplasty (NSR) was found to be 7.6%, with serious complications like ischemia and necrosis occurring in 0.20% of cases, indicating that while NSR is generally safe, there are risks involved.

Patients who had previously undergone surgical rhinoplasty experienced a higher AE rate of 10.8%, suggesting that prior surgery may alter nasal anatomy and increase the likelihood of complications during NSR.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nonsurgical Rhinoplasty Using Injectable Fillers: A Safety Review of 2488 Procedures. Rivkin, A.[2021]

Endoscopic septoplasty significantly improved nasal obstruction and other related symptoms compared to conventional septoplasty, with a higher change in nasal obstruction symptom evaluation score among 2733 patients studied.

Patients undergoing endoscopic septoplasty experienced fewer surgery-related complications, such as mucosal tearing and other post-operative issues, indicating it may be a safer option than traditional methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of endoscopic septoplasty for treating nasal septal deviations compared with conventional septoplasty: A systematic review and meta-analysis. Kim, DH., Kim, SW., Hwang, SH.[2023]

Functional septorhinoplasty significantly improves nasal passage obstruction, as evidenced by a notable increase in the Nose Obstruction Symptom Evaluation (NOSE) score from 35 to 60 points across 9 studies involving adults with anatomical nasal valve issues.

The study indicates that patients can expect meaningful improvements in their breathing difficulties within the first year after surgery, making functional septorhinoplasty a recommended option for those suffering from nasal valve obstructions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does Functional Septorhinoplasty Provide Improvement of the Nasal Passage in Validated Patient-Reported Outcome Measures? Menger, DJ., Richard, W., Swart, KM., et al.[2015]

The Guastella-Mantovani septal-valve splint is designed to promote proper healing of the internal nasal valve area after surgery, which is critical for maintaining nasal function.

This device also helps to orthopedically center the septum, potentially improving the overall outcomes of nasal surgeries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Guastella-Mantovani septal-valve splint: an intranasal biplanar and multivectorial orthopedic device. Mantovani, M., Guastella, C., Mazzola, RF.[2019]

The absorbable nasal implant for treating dynamic nasal valve collapse showed long-term efficacy, with over 80% of participants reporting significant improvement in nasal obstruction symptoms at 24 months, as measured by the NOSE scale.

The treatment was found to be safe, with no serious adverse events reported and a low implant migration rate of 9%, indicating that the implant provides durable symptom relief for patients with severe nasal obstruction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-Term Follow-up from the Treatment and Crossover Arms of a Randomized Controlled Trial of an Absorbable Nasal Implant for Dynamic Nasal Valve Collapse. Bikhazi, N., Ow, RA., O'Malley, EM., et al.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

Effects of Breathe Right on snoring: a polysomnographic study. [2019]

2. China pubmed.ncbi.nlm.nih.gov

[The value of nasal endoscopy in the resection of upper and posterior nasal septum deviation]. [2014]

3. United States pubmed.ncbi.nlm.nih.gov

Management of the deviated nose. The importance of septal reconstruction. [2004]

4. China pubmed.ncbi.nlm.nih.gov

[Septorhinoplasty for nasal deviation complicated with septal cartilage deformity]. [2006]

5. Ireland pubmed.ncbi.nlm.nih.gov

Efficiency of external nasal dilators in pediatric nasal septal deviation. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Adverse Events Associated With Bioabsorbable Nasal Implants: A MAUDE Database Analysis. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Nonsurgical Rhinoplasty Using Injectable Fillers: A Safety Review of 2488 Procedures. [2021]

8. England pubmed.ncbi.nlm.nih.gov

Efficacy and safety of endoscopic septoplasty for treating nasal septal deviations compared with conventional septoplasty: A systematic review and meta-analysis. [2023]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Does Functional Septorhinoplasty Provide Improvement of the Nasal Passage in Validated Patient-Reported Outcome Measures? [2015]

10. United States pubmed.ncbi.nlm.nih.gov

The Guastella-Mantovani septal-valve splint: an intranasal biplanar and multivectorial orthopedic device. [2019]

11. United States pubmed.ncbi.nlm.nih.gov

Long-Term Follow-up from the Treatment and Crossover Arms of a Randomized Controlled Trial of an Absorbable Nasal Implant for Dynamic Nasal Valve Collapse. [2022]