Clinical trial NCT06163404: Open-Label Study to Evaluate the Safety and Effectiveness of the Spirair Implant
Official title: A Prospective, Multi-Center, Open-Label Study to Evaluate the Safety and Effectiveness of the Spirair Implant for Correction of Cartilaginous Nasal Septal Deviation
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Nasal Septal Deviation
Nasal Airway Obstruction
Keywords: NAO
Septal Deviation
Mobile Cartilaginous Nasal Septal Deviation
Lead sponsor: Spirair, Inc
Sponsor class: INDUSTRY
First posted: 2023-12-08
Enrollment: 102
Sex: ALL
Minimum age (years): 21
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Device: Spirair NSD system for minimally invasive correction of nasal septal deviation.
Primary purpose: TREATMENT

Brief summary: Pilot study of bioabsorbable implant and delivery device for correction of septal deviation.

Detailed description: To evaluate the safety and effectiveness of the Spirair Implant as a primary treatment for correction of cartilaginous nasal septal deviation.

Eligibility criteria: Inclusion Criteria:

* ≥21 to ≤ 70 years of age at time of consent
* Seeking treatment for nasal airway obstruction (NAO) symptoms due primarily to cartilaginous nasal septal deviation
* Willing to undergo a nasal implant procedure
* NOSE score ≥30 at Baseline Visit
* Non-calcified, mobile cartilaginous nasal septal deviation

Exclusion Criteria:

* Target nasal septal deviation that is calcified or non-mobile
* Previous septoplasty or rhinoplasty
* Having a concurrent ENT procedure, other than turbinate reduction
* Saddle nose deformity
* Congenital nasal defect
* Documented evidence that middle meatus is not visualized on endoscopic exam due to severe septal deviation
* Turbinate reduction within the past six (6) months
* Permanent implant or dilator in the nose
* History of nasal vasculitis, unhealed wounds, cartilaginous nasal septal perforation or mucosal irregularities
* Active infection at the impllantation site e.g., folliculitis
* Current or chronic systemic steroid and/or has had radiation exposure or active chemotherapy in the treatment area
* 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 taking current prescription blood thinner medication
* Hypersensitivity to any investigational device materials inclusing known or suspected allergy to poly(dioxanone) (PDO) or other bioabsorbable materials
* Major medical condition that could affect quality of life or wound healing and influence the results of the study (e.g., poorly controlled diabetes, HIV or other immunosuppressive conditions, active malignancy in the past 5 years, acute MI, CVA, etc.)
* Active smoker or history of tobacco or tobacco-related product use within the past 1 year
* Documented evidence of a history (e.g., liver testing) of drug/alcohol abuse within 12 months of enrollment
* Females of child-bearing potential who are either pregnant or breastfeeding or plan to become pregnant during the course of the study
* Currently participating, or plans to enroll in another clinical trial during this study or undergo another nasal septal treatment during study participation
* History of non-compliance with medical treatment or clinical trial participation
* Subject is physically or mentally compromised (e.g., currently being treated for a psychiatric disorder, senile dementia, Alzheimer's disease, etc.), to the extent that the Investigator determines the subject to be unable or unlikely to comply with protocol required follow-up
* Any comorbidity or condition that renders the patient a poor surgical candidate as determined by the Investigator
* The subject is receiving prescription narcotic pain medication
* The subject's condition represents a worker's compensation case
* Symptoms of an upper respiratory infection e.g., runny nose, sneezing
* History of untreated or inadequately controlled rhinitis (allergic and/or nonallergic)

Primary outcomes:
measure: Primary Effectiveness Endpoint
timeFrame: 3 Months
measure: Primary Safety Endpoint
timeFrame: 3 Months
Secondary outcomes:
measure: Secondary Endpoint - 1
timeFrame: 12 Months
measure: Secondary Endpoint - 2
timeFrame: 12 Months
measure: Secondary Endpoint - 3
timeFrame: 12 Months
measure: Secondary Endpoint - 4
timeFrame: 12 Months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Alabama Nasal and Sinus Center
state: Alabama
city: Torrance
country: United States
facility: Breathe Clear Institute
state: California
city: Louisville
country: United States
facility: Kentuckiana Ear, Nose &amp; Throat
state: Kentucky
city: Baton Rouge
country: United States
facility: Sinus and Nasal Specialists of LA
state: Louisiana
city: Marrero
country: United States
facility: Tandem Clinical Research
state: Louisiana
city: Albany
country: United States
facility: Albany ENT & Allergy Services, PC
state: New York
city: Bethlehem
country: United States
facility: Specialty Physicians
state: Pennsylvania
city: Puyallup
country: United States
facility: Ear Nose Throat & Allergy Associates
state: Washington
Study officials:
affiliation: Spirair, CMO
name: Brandon McCutcheon, MD
role: STUDY_DIRECTOR
References: