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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02188589
Recruitment Status : Completed
First Posted : July 11, 2014
Results First Posted : October 10, 2016
Last Update Posted : March 26, 2019
Sponsor:
Information provided by (Responsible Party):
Spirox, Inc.

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

Condition or disease Intervention/treatment Phase
Nasal Valve Collapse Device: INEX nasal implant Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of an Absorbable Implant for the Treatment of Nasal Valve Collapse
Actual Study Start Date : April 2014
Actual Primary Completion Date : December 2015
Actual Study Completion Date : June 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shock

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)




Primary Outcome Measures :
  1. Implant-related Adverse Events [ Time Frame: 6 months ]
    Implant-related adverse events (such as implant retrievals, procedure-related hematoma/inflammation)


Secondary Outcome Measures :
  1. Breathing Capacity (NOSE Scores) [ Time Frame: At baseline and at 6, 12, and 24 months post implant ]
    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).

  2. NOSE Responder Rate [ Time Frame: At 6, 12, and 24 months post implant ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02188589


Locations
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Germany
Klinik und Poliklinik für Hals-Nasen-Ohren-Heilkunde am Klinikum der LMU
Munich, Germany, 81377
Sponsors and Collaborators
Spirox, Inc.
Investigators
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Principal Investigator: Alexander Berghaus, MD Ludwig-Maximilians - University of Munich
Publications of Results:
Other Publications:
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Responsible Party: Spirox, Inc.
ClinicalTrials.gov Identifier: NCT02188589    
Other Study ID Numbers: SPI-NVC-13001
First Posted: July 11, 2014    Key Record Dates
Results First Posted: October 10, 2016
Last Update Posted: March 26, 2019
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Shock
Pathologic Processes