Clinical trial NCT00729781: Study of Polyester Implants for the Treatment of External Nasal Valve Collapse (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
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Nasal Alar Collapse, Bilateral
Keywords: nasal obstruction
airway resistance
soft tissue collapse
cosmetic contour deformity
Lead sponsor: Medtronic Xomed, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Medtronic
First posted: 2008-08-08
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Functional Improvement
timeFrame: 12 weeks after implantation
measure: Cosmetic Improvement
timeFrame: 12 weeks after implantation
measure: Safety
timeFrame: During 12-week original study and at long-term follow-up of 11 months or longer
Secondary outcomes:
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: UC Davis Medical Center
state: California
city: Atlanta
country: United States
facility: Premier Image Cosmetic & Laser
state: Georgia
city: Downers Grove
country: United States
facility: DuPage Medical Group, Ltd
state: Illinois
city: Sterling Heights
country: United States
facility: Ear, Nose, & Throat Physicians
state: Michigan
city: St. Paul
country: United States
facility: HealthPartners Specialty Clinic/Regions Hospital
state: Minnesota
Study officials:
affiliation: Institute of Aesthetic Surgery
name: Terry L Donat, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.