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

Nasal Valve Collapse Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02188589
• Other study ID #: SPI-NVC-13001
• Status: Completed
• Phase: N/A
• Start date: April 2014
• Est. completion date: June 2017

Study information

• Verified date: November 2018
• Source: Spirox, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: June 2017
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Nasal Valve Collapse
• Shock

Intervention

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

Locations

Country	Name	City	State
Germany	Klinik und Poliklinik für Hals-Nasen-Ohren-Heilkunde am Klinikum der LMU	Munich

Sponsors (1)

Lead Sponsor	Collaborator
Spirox, Inc.

Country where clinical trial is conducted

Germany, 

References & Publications (3)

San Nicoló 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. — View Citation

San Nicoló 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Implant-related Adverse Events	Implant-related adverse events (such as implant retrievals, procedure-related hematoma/inflammation)	6 months
Secondary	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
Secondary	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