Study of Polyester Implants for the Treatment of External Nasal Valve Collapse (NVC)

This study has been terminated.
(Strategic Business Decision)
Sponsor:
Collaborator:
Medtronic
Information provided by (Responsible Party):
Medtronic Xomed, Inc.
ClinicalTrials.gov Identifier:
NCT00729781
First received: August 5, 2008
Last updated: December 1, 2011
Last verified: December 2011
  Purpose

The purpose of this study is to research a polyester polyethylene terephthalate (PET) implant for the treatment of external nasal valve collapse (NVC). NVC is a condition which causes narrowness and weakness in the nostril which results in nasal obstruction. Implants will be placed in the affected nostril(s). The implants are intended to restore the shape and stabilize the nasal wall to prevent nasal valve collapse and improve the symptoms associated with nasal obstruction.


Condition Intervention Phase
Nasal Alar Collapse, Bilateral
Device: Polyester Implants
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Open Label, Baseline Controlled Study to Evaluate the Use of Polyethylene Terephthalate (PET) Implants for the Treatment of External Nasal Valve Collapse and Cosmetic Contour Deformity

Resource links provided by NLM:


Further study details as provided by Medtronic Xomed, Inc.:

Primary Outcome Measures:
  • Functional Improvement [ Time Frame: 12 weeks after implantation ] [ Designated as safety issue: No ]
    Functional improvement was defined as a subject who achieves both 1) an improvement in the physical condition of the collapsed nasal valve as evidenced by an increase of >= 10% in the change in volume during inspiration as measured by Vectra 3D photography from baseline to 12 weeks post-procedure; and 2) a reduction of at least 30% in the symptoms of nasal obstruction as measured by the Nasal Obstruction Symptom Evaluation Scale (NOSE) scale (5 questions with 0-4 scale from "Not a problem" to "Severe problem," possible score 0-100 via raw score × 5) from baseline to 12 weeks post-procedure.

  • Cosmetic Improvement [ Time Frame: 12 weeks after implantation ] [ Designated as safety issue: No ]
    An independent clinician will review Vectra 3D photographs of each subject at baseline and at 12 weeks post-procedure to assess physical appearance of the external nasal wall. The clinician will be asked to determine which photographs are pre-treatment and which are post-treatment in the correct order. The clinician will then rate the photograph chosen as post-treatment using the Global Aesthetic Improvement Scale (GAIS; relative scale from "Worse" to "Very much improved"). If the post-treatment photograph was not correctly identified, that procedure will receive a "worse" on the rating scale.

  • Safety [ Time Frame: During 12-week original study and at long-term follow-up of 11 months or longer ] [ Designated as safety issue: Yes ]
    Evaluate complications and adverse events. Events are presented descriptively with no statistical analysis.


Enrollment: 45
Study Start Date: April 2008
Study Completion Date: January 2011
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Polyester Implants
There is one arm for this study. All subjects in this study will receive the investigational nasal implants. See the detailed description for procedure information.
Device: Polyester Implants
Three polyester (PET) implants will be implanted in each side of the nose affected by external NVC. See the detailed description for information about the implant procedure.
Other Names:
  • NVC-1000
  • The Pillar(R) Procedure
  • Pillar(R) Palatal Implants

Detailed Description:

The effects of PET implants on external NVC and cosmetic contour deformity will be evaluated in an open-label, prospective study. Subjects for this clinical study will be recruited and screened from clinic office visits and patient records at each principal investigator's site as well as through an investigational review board (IRB)-approved general advertisement. Those patients that continue to qualify after either screening process will be seen and evaluated by one of the clinical investigators prior to enrollment in the study. Subjects must meet criteria for the diagnosis of external nasal valve collapse as a stand alone abnormality (i.e., symptoms of obstruction cannot be caused primarily by other factors). Other contributing factors to the nasal obstruction must be ruled out and/or treated, without relief before enrollment in this study. No other surgeries or procedures will be allowed during the study that could influence the evaluation of implants on the treatment of nasal valve collapse and cosmetic contour deformity. All subjects will be required to sign an IRB approved informed consent prior to entry into the study.

After meeting inclusion/exclusion criteria and completing the pre-implant evaluations, subjects will be scheduled for treatment with the polyethylene terephthalate implants. The implant procedure will be performed by facial plastic physicians. All investigative sites will be required to undergo training to standardize the methodology of implant technique and administration of evaluation techniques (questionnaires, scales, photographic assessments, etc.). Target sample size for the study will be 72 subjects.

Follow up evaluations for all outcome measures will occur at 1, 6, and 12 weeks after implantation. Long-term follow-up for adverse events will be conducted at 11 months or later after implantation.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Is willing and able to sign an informed consent form
  • Is 18 years of age or older
  • Has positive response to any of the following based on patient history or office exam:

    • Use of Breath Rite Strips
    • Q-Tip test
    • Use of Nasal stents
    • Continuous manual distraction
  • Has inspiratory lateral nasal wall collapse or static medially obstructing lateral nasal wall position identified on physical exam
  • Has nasal valve that is narrow (either static or dynamic) based on a visual examination.
  • Has nasal septum that is considered stable and adequate to support the treatment of each nasal valve independently.
  • Is motivated and willing to comply with study and its follow-up requirements, including surgical intervention using the Pillar implant system for the treatment of nasal valve collapse
  • Speaks English
  • Has unilateral or bilateral nasal valve collapse

Exclusion Criteria:

  • Has ability to achieve active nostril dilation and relieve obstruction using physiologic nasal alar and sidewall muscle actions
  • Has chronic sinusitis, recurrent sinusitis, or allergies leading to nasal obstruction.
  • Has active nasal infection
  • Has skin inflammation in the nasal area
  • Is a habitual chronic sniffer
  • Has septal deviation, turbinate hypertrophy, polyps, or ptotic nose tip believed to be causing obstruction
  • Has had previous rhinoplasty of external nasal frame
  • Requires another surgery other than implants to correct an obstruction
  • Has nasal anatomy that is inadequate to accommodate three 18 mm implants
  • Is participating in a clinical study for another treatment for nasal valve collapse
  • Is pregnant or desires to become pregnant during the duration of the study
  • Has a history of drug abuse or alcoholism in the year before enrollment
  • Has had previous surgery for external nasal valve collapse
  • Has an American Society of Anesthesiologists (ASA) rating of III or IV
  • Has any other condition believed to interfere with nasal assessments
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00729781

Locations
United States, California
UC Davis Medical Center
Sacramento, California, United States, 95817-2207
United States, Georgia
Premier Image Cosmetic & Laser
Atlanta, Georgia, United States, 30338-6408
United States, Illinois
DuPage Medical Group, Ltd
Downers Grove, Illinois, United States, 60515
United States, Michigan
Ear, Nose, & Throat Physicians
Sterling Heights, Michigan, United States, 48314
United States, Minnesota
HealthPartners Specialty Clinic/Regions Hospital
St. Paul, Minnesota, United States, 55130
Sponsors and Collaborators
Medtronic Xomed, Inc.
Medtronic
Investigators
Principal Investigator: Terry L Donat, MD Institute of Aesthetic Surgery
  More Information

Publications:
Responsible Party: Medtronic Xomed, Inc.
ClinicalTrials.gov Identifier: NCT00729781     History of Changes
Other Study ID Numbers: 925
Study First Received: August 5, 2008
Results First Received: August 23, 2011
Last Updated: December 1, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Medtronic Xomed, Inc.:
nasal obstruction
airway resistance
soft tissue collapse
cosmetic contour deformity

Additional relevant MeSH terms:
Shock
Pathologic Processes

ClinicalTrials.gov processed this record on April 16, 2014