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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test a new bioabsorbable implant designed to correct a deviated septum, which can cause nasal airway obstruction. The Spirair Nasal Device improves breathing by adjusting the cartilage in the nasal passage. Individuals experiencing symptoms of blocked nasal passages due to a movable cartilage deviation might be suitable candidates, particularly if they have not undergone previous nasal surgeries like septoplasty. Participants should be willing to undergo a nasal implant procedure. As an unphased trial, this study offers a unique opportunity for patients to contribute to innovative research and potentially enhance their breathing.

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 prior data suggests that this implant and delivery device are safe for correcting septal deviation?

Research has shown that the Spirair Nasal Device is generally safe for people. This bioabsorbable implant, which the body can absorb, has been found well-tolerated in studies. One study found that after 12 months, the device was safe and effective for treating nasal septal deviation, a crooked wall between the two sides of the nose.

Another study reported that patients experienced relief from nasal blockage after using the device. Interim data from other research also showed the device remained safe six months after implantation. However, some similar implants have encountered issues. A different study on another bioabsorbable nasal implant reported problems like abscesses, which are pockets of pus.

Overall, while current data suggests the Spirair Nasal Device is safe, it is important to consider all potential risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Spirair Nasal Device is unique because it offers a minimally invasive approach to correcting a deviated septum. Traditional treatments often involve surgical procedures like septoplasty, which can be invasive and require longer recovery times. In contrast, the Spirair device is implanted with a delivery system designed to correct the deviation without major surgery. Researchers are excited about this treatment because it could provide a quicker, less invasive option for patients, potentially reducing recovery time and associated risks.

What evidence suggests that the Spirair Nasal Device is effective for correcting a deviated septum?

Research has shown that the Spirair Nasal Device, which participants in this trial will receive, is promising for treating nasal septal deviation, a crooked wall between the nostrils. One study found that this device greatly improved symptoms of a stuffy nose in patients. Designed to dissolve safely in the body over time, the device helps straighten the septum without removing any cartilage. Positive results from earlier research over 12 months demonstrated its safety and effectiveness. This less invasive method could offer a better experience for people with a deviated septum. ^{1 2 3 5 6}

Who Is on the Research Team?

Brandon McCutcheon, MD

Principal Investigator

Spirair, CMO

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

Citations

1. spirair.com spirair.com/news-and-updates/first-clinical-study-of-septalign-implant-demonstrates-safety-and-efficacy-in-treating-nasal-septal-deviation-while-preserving-cartilage/

First Clinical Study of SeptAlign™ Implant Demonstrates ... The positive 12-month outcomes demonstrate the safety and efficacy of this novel bioabsorbable device, which offers a cartilage-sparing approach ...

2. medicaleconomics.com medicaleconomics.com/view/spirair-announces-positive-results-from-first-clinical-study-of-septalign-nasal-implant

Spirair announces positive results from first clinical study ... Results show the device significantly improved symptoms of nasal obstruction in patients with nasal septal deviation.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05967169

NCT05967169 | EFS of Bioabsorbable Implant for NSD To obtain safety, device performance, patient tolerability and effectiveness outcome data in participants with cartilaginous septal deviations undergoing ...

4. withpower.com withpower.com/trial/phase-nasal-septal-deviation-10-2023-b7166

Spirair Implant for Deviated Septum 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 ...

5. spirair.com spirair.com/

Spirair: Minimally invasive septal deviation treatment Spirair is pioneering minimally invasive solutions that help ENTs advance care by providing strong outcomes and a better patient experience.

6. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf22/K223167.pdf

August 17, 2023 Spirair, Inc. Tracey Henry Regulatory ... Limited interim data was available out to six months and demonstrated that the Nasal Septal Strap was safe for implantation in nasal septal ...