Clinical trial NCT02188589: 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
Overall status: COMPLETED
Phase: NA
Conditions: Nasal Valve Collapse
Lead sponsor: Spirox, Inc.
Sponsor class: INDUSTRY
First posted: 2014-07-11
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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).

Primary outcomes:
measure: Implant-related Adverse Events
timeFrame: 6 months
Secondary outcomes:
measure: Breathing Capacity (NOSE Scores)
timeFrame: At baseline and at 6, 12, and 24 months post implant
measure: NOSE Responder Rate
timeFrame: At 6, 12, and 24 months post implant
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Klinik und Poliklinik für Hals-Nasen-Ohren-Heilkunde am Klinikum der LMU
Study officials:
affiliation: Ludwig-Maximilians - University of Munich
name: Alexander Berghaus, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.