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

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

Study Overview

• Status: Completed
• Conditions: Nasal Valve Collapse
• Intervention / Treatment: Device: INEX nasal implant

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Munich, Germany, 81377
    • Klinik und Poliklinik für Hals-Nasen-Ohren-Heilkunde am Klinikum der LMU

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Nasal implant group; Bilateral or unilateral INEX nasal implants	Device: INEX nasal implant; Treatment group may receive unilateral or bilateral INEX nasal implants (maximum of 4, 2 per side)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Implant-related Adverse Events	Implant-related adverse events (such as implant retrievals, procedure-related hematoma/inflammation)	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Breathing Capacity (NOSE Scores)	Nasal breathing capacity was assessed using the validated Nasal Obstruction Symptom Evaluation (NOSE) questionnaire. The NOSE score uses a 0-100 point scale to capture severity of nasal symptoms (congestion, obstruction, trouble breathing, sleeping, and exercise), with higher scores indicating more severe symptoms than lower scores. NOSE severity classes are defined as Mild (5-25), Moderate (30-50), Severe (55-75), and Extreme (80-100).	At baseline and at 6, 12, and 24 months post implant
NOSE Responder Rate	Percent of participants meeting responder criteria. Responders are defined as participants with a reduction from baseline in 1 or more Nasal Obstruction Symptom Evaluation Score (NOSE) severity class or a 20% reduction in the NOSE score.	At 6, 12, and 24 months post implant

Collaborators and Investigators

• Sponsor: Spirox, Inc.
• Investigators: Principal Investigator: Alexander Berghaus, MD, Ludwig-Maximilians - University of Munich

Publications and helpful links

General Publications

• Stewart MG, Witsell DL, Smith TL, Weaver EM, Yueh B, Hannley MT. Development and validation of the Nasal Obstruction Symptom Evaluation (NOSE) scale. Otolaryngol Head Neck Surg. 2004 Feb;130(2):157-63. doi: 10.1016/j.otohns.2003.09.016.
• San Nicolo M, Stelter K, Sadick H, Bas M, Berghaus A. Absorbable Implant to Treat Nasal Valve Collapse. Facial Plast Surg. 2017 Apr;33(2):233-240. doi: 10.1055/s-0037-1598655. Epub 2017 Apr 7. Erratum In: Facial Plast Surg. 2017 Jun;33(3):353-354.
• San Nicolo M, Stelter K, Sadick H, Bas M, Berghaus A. A 2-Year Follow-up Study of an Absorbable Implant to Treat Nasal Valve Collapse. Facial Plast Surg. 2018 Oct;34(5):545-550. doi: 10.1055/s-0038-1672213. Epub 2018 Sep 18.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2014
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): June 1, 2017

Study Registration Dates

• First Submitted: July 4, 2014
• First Submitted That Met QC Criteria: July 10, 2014
• First Posted (Estimate): July 11, 2014

Study Record Updates

• Last Update Posted (Actual): March 26, 2019
• Last Update Submitted That Met QC Criteria: March 14, 2019
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Shock
• Other Study ID Numbers: SPI-NVC-13001

Plan for Individual participant data (IPD)

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