N/A N=30 Treatment

Evaluation of an Absorbable Implant for the Treatment of Nasal Valve Collapse

Nasal Valve Collapse

Bottom Line

View on ClinicalTrials.gov: NCT02188589 ↗

Enrolled (actual)

Serious AEs

16.7%

Results posted

Oct 2016

Primary outcome: Primary: Implant-related Adverse Events — 5 participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: INEX nasal implant (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Spirox, Inc.
Primary completion: Dec 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY Implant-related Adverse Events	5	—
SECONDARY Breathing Capacity (NOSE Scores)	76.7; 33.3; 35.2; 32.0	<0.001 sig
SECONDARY NOSE Responder Rate	80.0; 76.7; 80.0	—

Summary

To evaluate the safety and feasibility of the INEX Nasal Implant in subjects with moderate to severe nasal valve collapse.

Eligibility Criteria

Eligible participants are:

Adult patients seeking treatment for nasal obstruction on one or both sides of the nose who are willing to undergo an office-based or intraoperative nasal implant procedure in lieu of alternative treatments (ie, surgical repair or use of an external dilator).
Nasal valve collapse (NVC) must be a primary or significant contributor to the subject's nasal obstruction based on clinical presentation, physical examination and nasal endoscopy.
Baseline Nasal Obstruction Symptom Evaluation (NOSE) score must be ≥55.

Participants are excluded for the following:

Surgical or non-surgical treatment of the nasal valve or rhinoplasty within 12 months before enrollment.
Septoplasty, inferior turbinate reduction, or other surgical nasal procedures within 6 months before enrollment.
Recurrent nasal infections.
Use of intranasal steroids within 2 weeks preimplant and 2 weeks post implantation.
Presence of a permanent implant, dilator, or uses an external device in the nasal area.
Cancerous or precancerous lesions and/or radiation exposure in the treatment area or chemotherapy within 24 months of the study.
Significant bleeding disorders.
Significant systemic diseases.
Currently using nasal oxygen or continuous positive airway pressure (CPAP).

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02188589). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.