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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02188589
First Posted: July 11, 2014
Last Update Posted: February 23, 2017
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.
Information provided by (Responsible Party):
Spirox, Inc.
  Purpose
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: None (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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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

Publications:
Responsible Party: Spirox, Inc.
ClinicalTrials.gov Identifier: NCT02188589     History of Changes
Other Study ID Numbers: SPI-NVC-13001
First Submitted: July 4, 2014
First Posted: July 11, 2014
Results First Submitted: June 17, 2016
Results First Posted: October 10, 2016
Last Update Posted: February 23, 2017
Last Verified: August 2016

Additional relevant MeSH terms:
Shock
Pathologic Processes