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

Spirox

Status: Completed

Conditions: Nasal Valve Collapse

Treatments: Device: INEX nasal implant

Study type: Interventional

Funder types: Industry

Identifiers

NCT02188589

SPI-NVC-13001

Details and patient eligibility

About

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

Full description

This study is a multicenter, nonrandomized, prospective exploratory study of the INEX Nasal Implant. The purpose of this study is to evaluate the safety and feasibility of the INEX Nasal Implant in subjects with moderate to severe nasal valve collapse.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Eligible participants are:

1. 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).
2. 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.
3. Baseline Nasal Obstruction Symptom Evaluation (NOSE) score must be ≥55.

Participants are excluded for the following:

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

30 participants in 1 patient group

Nasal implant group

Experimental group

Description:

Bilateral or unilateral INEX nasal implants

Treatment:

Device: INEX nasal implant