Spirair Implant for Deviated Septum
Recruiting in Palo Alto (17 mi)
+10 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
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
Approved in 1 Jurisdiction
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.
12345What 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.
26789How 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.
2341011Eligibility 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.
+4 more
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
+25 more
Trial 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
Participant Groups
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.
1Treatment groups
Experimental Treatment
Group I: Investigational DeviceExperimental Treatment1 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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Kentuckiana Ear, Nose & ThroatLouisville, KY
Breathe Clear InstituteTorrance, CA
Kentuckiana Ear, Nose & ThroatLouisville, KY
Specialty PhysiciansBethlehem, PA
More Trial Locations
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Who Is Running the Clinical Trial?
Spirair, IncLead Sponsor
References
Effects of Breathe Right on snoring: a polysomnographic study. [2019]The nasal vestibule is a major site of resistance to airflow in healthy subjects. A high nasal resistance may increase snoring. Activation of the alae nasi and alar retraction reduce resistance to airflow and improve ventilation. The Breathe Right (BR) device has been proposed to reduce or eliminate snoring by improving nasal breathing. We assessed the efficacy of BR on sleep quality and snoring during 2 full-night polysomnographies, the first without and the second with BR. Ten non-apnoeic snorers were studied. Snoring was present during 22-98% of total sleep time during the control night. Ear-nose-throat examination disclosed a nasal valve anomaly in five subjects, objectivated by anterior and posterior rhinomanometry. Quality of sleep and snoring were not influenced by BR, even when different sleep stages were analysed separately. No difference in snoring index was found between snorers with or without nasal valve anomaly. We conclude that BR is ineffective in relieving snoring in non-apnoeic snorers.
[The value of nasal endoscopy in the resection of upper and posterior nasal septum deviation]. [2014]In order to find a safe, reliable and satisfying technique to treat the upper and posterior nasal septum deviation.
Management of the deviated nose. The importance of septal reconstruction. [2004]The key to the correction of severely deviated noses is straightening the nasal septum. An emphasis is placed on conservative management of the external nasal framework while being prepared to perform extensive surgery on the deviated septum. If the septum can be modified and repositioned in the midline without losing support to the nose, consistently good functional and aesthetic results are obtained. Several techniques that we have found to be of value in achieving this goal have been discussed and illustrated and three representative cases have been presented.
[Septorhinoplasty for nasal deviation complicated with septal cartilage deformity]. [2006]To investigate a method for safe, simple and effective correction of nasal deviation complicated with the deformity of nasal septal cartilage.
Efficiency of external nasal dilators in pediatric nasal septal deviation. [2022]Nasal septal deviation results from irregular development of the nasomaxillary complex and trauma. Treatment of nasal septal deviation in pediatric patients is one of the biggest challenges in rhinology. Surgery may alter craniofacial growth patterns, and so it may be indicated only in the selected cases. The use of external nasal dilators is a relatively new treatment modality in nasal obstruction.
Adverse Events Associated With Bioabsorbable Nasal Implants: A MAUDE Database Analysis. [2023]Bioabsorbable implants (eg, Latera) have recently been approved for addressing nasal valve collapse. The purpose of this study is to summarize adverse events and treatment sequelae associated with bioabsorbable nasal implants queried in the Manufacturer and User Facility Device Experience (MAUDE) database. Of the 26 device reports entered between March 2017 and April 2022, the most frequently reported complications included abscess (n = 13) and implant protrusion (n = 5). Other common symptoms reported greater than 1-year postimplantation included facial pain/discomfort (n = 3) and failure to absorb (n = 3). Management of adverse events included treatment with antibiotics (n = 9), steroid injections (n = 4), and explantation (n = 20). In 3 reports, adverse reactions required a biopsy of adjacent tissue for pathologic analysis. These findings suggest that further research is required to assess the potential long-term complications and optimize the management of bioabsorbable nasal implants. Furthermore, standardized reporting templates may improve the utility of the MAUDE database.
Nonsurgical Rhinoplasty Using Injectable Fillers: A Safety Review of 2488 Procedures. [2021]Background: Injectable fillers are used worldwide to improve the appearance of the nose by nonsurgical methods. The procedure is not without risks, as blindness and skin necrosis have been reported as a consequence of filler injections in the nose. Objective: To determine an overall adverse event (AE) rate for the nonsurgical rhinoplasty (NSR) procedure and to assess whether previous surgical rhinoplasty increases the odds of an AE. Methods: A retrospective chart review of 2275 patients and 2488 NSR procedures for a 10-year period from a single physician injector was conducted. Results: The overall procedural AE rate was 7.6%, with five cases (0.20%) considered serious (ischemia and necrosis). Previous surgical rhinoplasty patients had a greater AE rate (10.8%) than those patients without previous surgery (7.4%), with a significant odds ratio of 1.51 (95% confidence interval: 1.03-2.18); p = 0.032. Injecting the tip and sidewall of the nose had the highest AE rates for both categories of patients. Conclusions: NSR is a relatively safe procedure with the majority of AEs common injection site reactions. Patients with previous surgical rhinoplasty demonstrated significantly increased odds of an AE potentially due to surgical changes in anatomy.
Efficacy and safety of endoscopic septoplasty for treating nasal septal deviations compared with conventional septoplasty: A systematic review and meta-analysis. [2023]We assessed the effects and safety of endoscopic septoplasty in patients with nasal septal deviations (NSD), compared with those of conventional septoplasty.
Does Functional Septorhinoplasty Provide Improvement of the Nasal Passage in Validated Patient-Reported Outcome Measures? [2015]The aim of this study was to determine whether functional septorhinoplasty provides improvement of the nasal passage in validated patient-reported outcome measures (PROMs) for adults with an anatomical obstruction of the nasal valve. All patients with an anatomical obstruction of the nasal valve area due to nasal valve pathology and/or septal deviations in this area were included.
The Guastella-Mantovani septal-valve splint: an intranasal biplanar and multivectorial orthopedic device. [2019]A new internal nasal device, the Guastella-Mantovani septal-valve splint, ensures the correct healing of the crucial area of the internal valve, simultaneously "centering" the septum orthopedically after nasal surgery.
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]We report the long-term safety and efficacy outcomes of the treatment and crossover arms of a randomized controlled trial evaluating an absorbable nasal implant to address dynamic nasal valve collapse. Participants were adults with severe/extreme nasal airway obstruction primarily due to nasal valve insufficiency who had implant placement. Follow-up visits were at 3, 6, 12, 18, and 24 months post implant. Visits included collection of the following patient-reported outcome measures: nasal obstructive symptom evaluation (NOSE), nasal obstruction visual analog scale (VAS), and the Epworth Sleepiness Scale (ESS). Adverse events were evaluated at each visit. One-hundred-eleven participants with implants were followed. Of the 111, 90 completed the 12-month visit and 70 completed the 24-month visit. NOSE responder rates are greater than 80% at all follow-ups through 24 months. Mean reduction from baseline in NOSE scores is ≥30 points and statistically significant (p <0.001) at all time points through 24 months. Mean VAS score reduction is ≥29.7 points and statistically significant (p <0.001) at all time points. The subgroup of participants with baseline ESS values >10 experienced statistically significant (p <0.001) and clinically meaningful reductions at all postimplant periods, suggesting that the reduction in nasal symptoms may reduce daytime sleepiness for patients who have problems with sleep quality. No serious device-/procedure-related adverse events were reported. Implant migration/retrieval rate was 4.5% (10/222) of total implants or 9% of participants (10/111). The implant is safe and effective for dynamic nasal valve collapse in patients with severe/extreme nasal obstruction and provides durable symptom improvement 24 months after placement.