EFS of Bioabsorbable Implant for NSD

Early Feasibility Study of Bioabsorbable Polydioxanone Implant and Delivery Device for Correction of Cartilaginous Septal Deviation

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

Study Overview

• Status: Completed
• Conditions: Nasal Septal Deviation
• Intervention / Treatment: Device: Nasal Septal Strap implantation

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.

• Study Type: Interventional
• Enrollment (Actual): 21
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Torrance, California, United States, 90503
      • Breathe Clear Institute
  • Pennsylvania
    • Bethlehem, Pennsylvania, United States, 18017
      • Specialty Physicians

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort 1; Index Procedure in OR, placement of one implant	Device: Nasal Septal Strap implantation; Correction of NSD with Nasal Septal Strap implant
Experimental: Cohort 2; Index Procedure in office or OR, placement of one implant	Device: Nasal Septal Strap implantation; Correction of NSD with Nasal Septal Strap implant
Experimental: Cohort 3; Index Procedure in OR, placement of up to two implant	Device: Nasal Septal Strap implantation; Correction of NSD with Nasal Septal Strap implant

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with successful implantation as measured through physician's assessment and patient reported outcomes	Feasibility of implantation and durability of Implant through the healing process	24 months

Collaborators and Investigators

• Sponsor: Spirair, Inc

Publications and helpful links

General Publications

• Davis SE, Davis GE. The Safety and Efficacy of a Bioabsorbable Implant for Correction of Cartilaginous Septal Deviation. Ear Nose Throat J. 2025 Jun 4:1455613251346589. doi: 10.1177/01455613251346589. Online ahead of print.

Study record dates

Study Major Dates

• Study Start (Actual): May 25, 2022
• Primary Completion (Actual): October 16, 2025
• Study Completion (Actual): March 23, 2026

Study Registration Dates

• First Submitted: July 13, 2023
• First Submitted That Met QC Criteria: July 21, 2023
• First Posted (Actual): August 1, 2023

Study Record Updates

• Last Update Posted (Actual): April 30, 2026
• Last Update Submitted That Met QC Criteria: April 24, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: CT-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No