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

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Spirox, Inc. Identifier:
First received: July 4, 2014
Last updated: January 1, 2017
Last verified: August 2016
To evaluate the safety and feasibility of the INEX Nasal Implant in subjects with moderate to severe nasal valve collapse.

Condition Intervention
Nasal Valve Collapse
Device: Nasal implant

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of an Absorbable Implant for the Treatment of Nasal Valve Collapse

Resource links provided by NLM:

Further study details as provided by Spirox, Inc.:

Primary Outcome Measures:
  • Implant Related Adverse Events [ Time Frame: 6 months ]
    Implant related adverse events

Secondary Outcome Measures:
  • Secondary Efficacy Endpoint [ Time Frame: 6 months ]
    Nasal patency assessed by validated NOSE ("Nasal Obstruction Symptom Evaluation") Questionnaire. The NOSE score uses a 0 - 20 point scale to capture severity of breathing symptoms, with higher scores indicating more severe symptoms than lower scores. NOSE scores are converted to a 100-point scale by multiplying the total score by 5.

Enrollment: 30
Study Start Date: May 2014
Estimated Study Completion Date: May 2017
Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Treatment group
Bilateral or unilateral implants
Device: Nasal implant
Treatment group may receive bilateral nasal implants (maximum of 4, 2 per side)

Detailed Description:
This study is a Multi-Center, Non-Randomized, 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.

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

Inclusion Criteria:

  • 1) The subject is ≥ 18 years of age. 2) The subject is willing and able to provide informed consent. 3) The subject is willing and able to comply with the study protocol. 4) The subject is seeking treatment for nasal obstruction on one or both sides of the nose and is willing to undergo an office-based or intraoperative nasal implant procedure in lieu of alternative treatments (i.e., surgical repair or use of an external dilator).

    5) The subject has a baseline NOSE Score ≥ 11. 6) The subject agrees to follow-up examinations for 18 months post treatment. 7) The investigator has determined that nasal valve collapse (NVC) is a primary or significant contributor to the subject's nasal obstruction based on clinical presentation, physical examination and nasal endoscopy.

    8) Patient agrees to have mupirocin ointment prior to implantation. 9) The subject has sufficient space available to receive the implant and the shape of the maxilla allows for an appropriate anchor location.

    10) The subject has been offered other available treatments and declined such treatments.

Exclusion Criteria:

  • 1) The subject has had concomitant surgical or non-surgical treatment of their nasal valve or the subject has had prior rhinoplasty within 12 months.

    2) The subject has had septoplasty, inferior turbinate reduction or other surgical nasal procedures within the past six (6) months.

    3) The subject has had recurrent methicillin-resistant Staphylococcus aureas (MRSA) infections or has a current Staphylococcus infection.

    4) The subject plans to have concomitant surgical or non-surgical treatment of their nasal valve within 6 months of the study (through 6 month follow-up).

    5) The subject has used or plans to use intranasal steroids during treatment (within 2 weeks pre-implant and 2 weeks post implantation).

    6) The subject has a permanent implant, dilator and/or uses an external device in the nasal area.

    7) The subject has concomitant inflammatory or infectious skin conditions or unhealed wounds in the treatment area.

    8) The subject has a cancerous or pre-cancerous lesion and/or has had radiation exposure in the treatment area or chemotherapy within 24 months of the study.

    9) The subject has known or suspected allergies or contraindications for any general or local anesthetic agents and / or any antibiotic medications.

    10) The subject has a history of significant bleeding disorders. 11) The subject is known or suspected to be pregnant or is lactating. 12) The subject has a known or suspected allergy to PLA or other bioresorbable materials.

    13) The subject has significant systemic disease such as chronic steroid use or poorly controlled diabetes which in the investigator's opinion could pre-dispose the subject to poor wound healing.

    14) The subject is currently using nasal oxygen or CPAP. 15) The subject is not a candidate for procedures conducted under general anesthesia.

  Contacts and Locations
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Please refer to this study by its identifier: NCT02188589

Klinik und Poliklinik für Hals-Nasen-Ohren-Heilkunde am Klinikum der LMU
Munich, Germany, 81377
Sponsors and Collaborators
Spirox, Inc.
Principal Investigator: Alexander Berghaus, MD Ludwig-Maximilians - University of Munich
  More Information

Responsible Party: Spirox, Inc. Identifier: NCT02188589     History of Changes
Other Study ID Numbers: SPI-NVC-13001
Study First Received: July 4, 2014
Results First Received: June 17, 2016
Last Updated: January 1, 2017

Additional relevant MeSH terms:
Pathologic Processes processed this record on April 28, 2017