EFS of Bioabsorbable Implant for NSD

April 24, 2026 updated by: Spirair, Inc

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
21

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of participants with successful implantation as measured through physician's assessment and patient reported outcomes
Time Frame: 24 months
Feasibility of implantation and durability of Implant through the healing process
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Spirair, Inc

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 25, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 16, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 23, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 13, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 21, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 1, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 30, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 24, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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