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

Primary Purpose

Nasal Alar Collapse, Bilateral

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Polyester Implants
Sponsored by
Medtronic Xomed, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nasal Alar Collapse, Bilateral focused on measuring nasal obstruction, airway resistance, soft tissue collapse, cosmetic contour deformity

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • UC Davis Medical Center
  • Premier Image Cosmetic & Laser
  • DuPage Medical Group, Ltd
  • Ear, Nose, & Throat Physicians
  • HealthPartners Specialty Clinic/Regions Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Polyester Implants

Arm Description

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.

Outcomes

Primary Outcome Measures

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.
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.
Safety
Evaluate complications and adverse events. Events are presented descriptively with no statistical analysis.

Secondary Outcome Measures

Full Information

First Posted
August 5, 2008
Last Updated
December 1, 2011
Sponsor
Medtronic Xomed, Inc.
Collaborators
Medtronic
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1. Study Identification

Unique Protocol Identification Number
NCT00729781
Brief Title
Study of Polyester Implants for the Treatment of External Nasal Valve Collapse (NVC)
Acronym
NVC
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2011
Overall Recruitment Status
Terminated
Why Stopped
Strategic Business Decision
Study Start Date
April 2008 (undefined)
Primary Completion Date
November 2009 (Actual)
Study Completion Date
January 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medtronic Xomed, Inc.
Collaborators
Medtronic

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nasal Alar Collapse, Bilateral
Keywords
nasal obstruction, airway resistance, soft tissue collapse, cosmetic contour deformity

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Polyester Implants
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Polyester Implants
Other Intervention Name(s)
NVC-1000, The Pillar(R) Procedure, Pillar(R) Palatal Implants
Intervention Description
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.
Primary Outcome Measure Information:
Title
Functional Improvement
Description
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.
Time Frame
12 weeks after implantation
Title
Cosmetic Improvement
Description
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.
Time Frame
12 weeks after implantation
Title
Safety
Description
Evaluate complications and adverse events. Events are presented descriptively with no statistical analysis.
Time Frame
During 12-week original study and at long-term follow-up of 11 months or longer

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Terry L Donat, MD
Organizational Affiliation
Institute of Aesthetic Surgery
Official's Role
Principal Investigator
Facility Information:
Facility Name
UC Davis Medical Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817-2207
Country
United States
Facility Name
Premier Image Cosmetic & Laser
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30338-6408
Country
United States
Facility Name
DuPage Medical Group, Ltd
City
Downers Grove
State/Province
Illinois
ZIP/Postal Code
60515
Country
United States
Facility Name
Ear, Nose, & Throat Physicians
City
Sterling Heights
State/Province
Michigan
ZIP/Postal Code
48314
Country
United States
Facility Name
HealthPartners Specialty Clinic/Regions Hospital
City
St. Paul
State/Province
Minnesota
ZIP/Postal Code
55130
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
16549736
Citation
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.
Results Reference
background
PubMed Identifier
14990910
Citation
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.
Results Reference
background

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

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