Clinical trial NCT05967169: EFS of Bioabsorbable Implant for NSD
Official title: Early Feasibility Study of Bioabsorbable Polydioxanone Implant and Delivery Device for Correction of Cartilaginous Septal Deviation
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Nasal Septal Deviation
Lead sponsor: Spirair, Inc
Sponsor class: INDUSTRY
First posted: 2023-08-01
Enrollment: 30
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Multi-cohort
Primary purpose: TREATMENT

Brief summary: Early feasibility study of bioabsorbable implant and delivery device for correction of septal deviation

Detailed description: To obtain safety, device performance, patient tolerability and effectiveness outcome data in participants with cartilaginous septal deviations undergoing placement of the Spirair Implant with the Spirair delivery device.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of participants with successful implantation as measured through physician's assessment and patient reported outcomes
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Torrance
country: United States
facility: Breathe Clear Institute
state: California
city: Bethlehem
country: United States
facility: Specialty Physicians
state: Pennsylvania
Study officials:
References: