NCT05967169

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 25, 2022

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

July 13, 2023

Completed
19 days until next milestone

First Posted

Study publicly available on registry

August 1, 2023

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 16, 2025

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 23, 2026

Completed
Last Updated

April 30, 2026

Status Verified

April 1, 2026

Enrollment Period

3.4 years

First QC Date

July 13, 2023

Last Update Submit

April 24, 2026

Conditions

Nasal Septal Deviation

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (3)

Cohort 1

EXPERIMENTAL

Index Procedure in OR, placement of one implant

Device: Nasal Septal Strap implantation

Cohort 2

EXPERIMENTAL

Index Procedure in office or OR, placement of one implant

Device: Nasal Septal Strap implantation

Cohort 3

EXPERIMENTAL

Index Procedure in OR, placement of up to two implant

Device: Nasal Septal Strap implantation

Interventions

Nasal Septal Strap implantationDEVICE

Correction of NSD with Nasal Septal Strap implant

Cohort 1Cohort 2Cohort 3

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Breathe Clear Institute

Torrance, California, 90503, United States

Location

Specialty Physicians

Bethlehem, Pennsylvania, 18017, United States

Location

Related Publications (1)

  • 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.

    PMID: 40468718DERIVED

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Multi-cohort
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 13, 2023

First Posted

August 1, 2023

Study Start

May 25, 2022

Primary Completion

October 16, 2025

Study Completion

March 23, 2026

Last Updated

April 30, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

US(2)