Nasal Alar Collapse, BilateralPhase 1/2NVCNCT00729781
Study of Polyester Implants for the Treatment of External Nasal Valve Collapse (NVC)
A Phase 1/2 study testing Polyester Implants in people with Nasal Alar Collapse, Bilateral, run by Medtronic Xomed, Inc. at 5 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nasal Alar Collapse, Bilateral
- What is being tested?
- Polyester Implants
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 5 sitesUnited States
- Study dates
- Apr 2008to Jan 2011
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Premier Image Cosmetic & Laser
Atlanta, Georgia, 30338-6408
DuPage Medical Group, Ltd
Downers Grove, Illinois, 60515
UC Davis Medical Center
Sacramento, California, 95817-2207
HealthPartners Specialty Clinic/Regions Hospital
Saint Paul, Minnesota, 55130
Ear, Nose, & Throat Physicians
Sterling Heights, Michigan, 48314
About this study
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
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.
Read the 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.
- Conditions
- Nasal Alar Collapse, Bilateral
- Being tested
- Polyester Implants
- Keywords
- nasal obstruction, airway resistance, soft tissue collapse, cosmetic contour deformity
- Medical subject headings
- Nasal Alar Collapse, Bilateral, Nasal Obstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Polyester ImplantsDevice
Also called NVC-1000, The Pillar(R) Procedure, Pillar(R) Palatal 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Polyester Implants |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 12 weeks after implantation
Safety
Evaluate complications and adverse events. Events are presented descriptively with no statistical analysis.
Measured: During 12-week original study and at long-term follow-up of 11 months or longer
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2008 (estimated)
- Study startApr 2008
- Primary completionNov 2009
- Study completionJan 2011
Why it stopped: Strategic Business Decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Nasal Alar Collapse, BilateralStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Xomed, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Medtronic
- Responsible party
- Sponsor
- Investigators
- Terry L Donat, MD, Principal investigator, Institute of Aesthetic Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00729781
- Sponsor's protocol ID
- 925
- Acronym
- NVC
- Status last verified
- Dec 2011
- First submitted
- 5 Aug 2008
- Last updated
- 6 Jan 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
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.
PubMed 16549736Stewart 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.
PubMed 14990910
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00729781
- Acronym / sponsor ID
- NVC / 925
- Conditions
- Nasal Alar Collapse, Bilateral
- Keywords
- nasal obstruction, airway resistance, soft tissue collapse, cosmetic contour deformity
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Strategic Business Decision
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Medtronic Xomed, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Medtronic
- Study start
- Apr 2008
- Primary completion
- Nov 2009 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 8 Aug 2008 (estimated)
- Results
- Posted 6 Jan 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Polyester Implants | Experimental | Device: Polyester ImplantsThere is one arm for this study. All subjects in this study will receive the investigational nasal implants. See the detailed description for procedure information. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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:
- 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.
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Polyester ImplantsAlso: NVC-1000, The Pillar(R) Procedure, Pillar(R) Palatal ImplantsThree 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. | Device | Polyester Implants |
Primary outcome
Functional Improvement
Time frame: 12 weeks after implantation
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
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
Evaluate complications and adverse events. Events are presented descriptively with no statistical analysis.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 16549736Hurbis 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.
- Background: PubMed 14990910Stewart 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.
Related trials for Nasal Alar Collapse, Bilateral
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Terry L Donat, MD principal investigator
Institute of Aesthetic Surgery
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Polyester Implants in people with Nasal Alar Collapse, Bilateral, run by Medtronic Xomed, Inc. at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Jan 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional Improvement (time frame: 12 weeks after implantation). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00729781, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2012.