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

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

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.

Study Overview

• Status: Terminated
• Conditions: Nasal Alar Collapse, Bilateral
• Intervention / Treatment: Device: Polyester 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.

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Sacramento, California, United States, 95817-2207
      • UC Davis Medical Center
  • Georgia
    • Atlanta, Georgia, United States, 30338-6408
      • Premier Image Cosmetic & Laser
  • Illinois
    • Downers Grove, Illinois, United States, 60515
      • DuPage Medical Group, Ltd
  • Michigan
    • Sterling Heights, Michigan, United States, 48314
      • Ear, Nose, & Throat Physicians
  • Minnesota
    • St. Paul, Minnesota, United States, 55130
      • HealthPartners Specialty Clinic/Regions Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional Improvement	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.	12 weeks after implantation
Cosmetic Improvement	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.	12 weeks after implantation
Safety	Evaluate complications and adverse events. Events are presented descriptively with no statistical analysis.	During 12-week original study and at long-term follow-up of 11 months or longer

Collaborators and Investigators

• Sponsor: Medtronic Xomed, Inc.
• Collaborators: Medtronic
• Investigators: Principal Investigator: Terry L Donat, MD, Institute of Aesthetic Surgery

Publications and helpful links

General Publications

• Hurbis CG. An adjustable, butterfly-design, titanium-expanded polytetrafluoroethylene implant for nasal valve dysfunction: a pilot study. Arch Facial Plast Surg. 2006 Mar-Apr;8(2):98-104. doi: 10.1001/archfaci.8.2.98.
• 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.

Study record dates

Study Major Dates

• Study Start: April 1, 2008
• Primary Completion (ACTUAL): November 1, 2009
• Study Completion (ACTUAL): January 1, 2011

Study Registration Dates

• First Submitted: August 5, 2008
• First Submitted That Met QC Criteria: August 7, 2008
• First Posted (ESTIMATE): August 8, 2008

Study Record Updates

• Last Update Posted (ESTIMATE): January 6, 2012
• Last Update Submitted That Met QC Criteria: December 1, 2011
• Last Verified: December 1, 2011

More Information

Terms related to this study

• Keywords: airway resistance; nasal obstruction; soft tissue collapse; cosmetic contour deformity
• Additional Relevant MeSH Terms: Pathologic Processes; Shock
• Other Study ID Numbers: 925