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

NCT00729781 | Terminated Phase 1 Results

• 1 other identifier: 925
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 5

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.

Conditions

Nasal Alar Collapse, Bilateral

Keywords

nasal obstruction; airway resistance; soft tissue collapse; cosmetic contour deformity

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (1)

Polyester Implants

EXPERIMENTAL

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

Interventions

Polyester Implants DEVICE

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.

Also known as: NVC-1000, The Pillar(R) Procedure, Pillar(R) Palatal Implants

Polyester Implants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medtronic Xomed, Inc.: lead
• Medtronic: collaborator

Study Sites (5)

UC Davis Medical Center

Sacramento, California, 95817-2207, United States

Location

Premier Image Cosmetic & Laser

Atlanta, Georgia, 30338-6408, United States

Location

DuPage Medical Group, Ltd

Downers Grove, Illinois, 60515, United States

Location

Ear, Nose, & Throat Physicians

Sterling Heights, Michigan, 48314, United States

Location

HealthPartners Specialty Clinic/Regions Hospital

Saint Paul, Minnesota, 55130, United States

Location

Related Publications (2)

• 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.

  PMID: 16549736 BACKGROUND

• 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.

  PMID: 14990910 BACKGROUND

MeSH Terms

Conditions

Nasal Alar Collapse, Bilateral; Nasal Obstruction

Condition Hierarchy (Ancestors)

Nose Diseases; Respiratory Tract Diseases; Airway Obstruction; Respiratory Insufficiency; Respiration Disorders; Otorhinolaryngologic Diseases

Results Point of Contact

• Title: David Hodge, Project Manager
• Organization: Medtronic Xomed, Inc.

david.l.hodge@medtronic.com

(+1-904) 281-2774

Study Officials

• Terry L Donat, MD

  Institute of Aesthetic Surgery

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2008
• First Posted: August 8, 2008
• Study Start: April 1, 2008
• Primary Completion: November 1, 2009
• Study Completion: January 1, 2011
• Last Updated: January 6, 2012
• Results First Posted: January 6, 2012

Record last verified: 2011-12

Locations

US (5)