Back to results

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

Primary Purpose

Nasal Valve Collapse

Status

Completed

Phase

Not Applicable

Locations

Germany

Study Type

Interventional

Intervention

INEX nasal implant

About this trial

This is an interventional treatment trial for Nasal Valve Collapse

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

Klinik und Poliklinik für Hals-Nasen-Ohren-Heilkunde am Klinikum der LMU

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Nasal implant group

Arm Description

Bilateral or unilateral INEX nasal implants

Outcomes

Primary Outcome Measures

Implant-related Adverse Events

Implant-related adverse events (such as implant retrievals, procedure-related hematoma/inflammation)

Secondary Outcome Measures

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).

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.

Full Information

NCT ID

NCT02188589

First Posted

July 4, 2014

Last Updated

March 14, 2019

Sponsor

Spirox, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT02188589

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2018

Overall Recruitment Status

Completed

Study Start Date

April 2014 (Actual)

Primary Completion Date

December 2015 (Actual)

Study Completion Date

June 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Spirox, Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Nasal Valve Collapse

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Nasal implant group

Arm Type

Experimental

Arm Description

Bilateral or unilateral INEX nasal implants

Intervention Type

Device

Intervention Name(s)

INEX nasal implant

Intervention Description

Treatment group may receive unilateral or bilateral INEX nasal implants (maximum of 4, 2 per side)

Primary Outcome Measure Information:

Title

Implant-related Adverse Events

Description

Implant-related adverse events (such as implant retrievals, procedure-related hematoma/inflammation)

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Breathing Capacity (NOSE Scores)

Description

Time Frame

At baseline and at 6, 12, and 24 months post implant

Title

NOSE Responder Rate

Description

Time Frame

At 6, 12, and 24 months post implant

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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).

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Alexander Berghaus, MD

Organizational Affiliation

Ludwig-Maximilians - University of Munich

Official's Role

Principal Investigator

Facility Information:

Facility Name

Klinik und Poliklinik für Hals-Nasen-Ohren-Heilkunde am Klinikum der LMU

City

Munich

ZIP/Postal Code

81377

Country

Germany

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

14990910

Citation

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.

Results Reference

background

PubMed Identifier

28388804

Citation

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.

Results Reference

result

PubMed Identifier

30227454

Citation

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.

Results Reference

result

Learn more about this trial

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

We'll reach out to this number within 24 hrs