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

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Nasal Alar Collapse, Bilateral
Intervention:	Device: Polyester Implants

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Polyester Implants	There was one arm for this study. All subjects in this study received the investigational polyethylene terephthalate (PET) implants after enrollment in the original study. Subjects who could be reached and consented were enrolled in the long-term follow-up study, which was initiated to collect adverse events. See the detailed description for procedure information.

Participant Flow for 2 periods

Period 1: Original Study

	Polyester Implants
STARTED	45
COMPLETED	45
NOT COMPLETED	0

Period 2: Long-term Follow-up Study

	Polyester Implants
STARTED	42 ^[1]
COMPLETED	42 ^[2]
NOT COMPLETED	0

[1]	Enrollment in the long-term follow-up required contact and a new Informed Consent.
[2]	All subjects completed the original study, but 3 did not consent to enroll in the follow-up study.

Baseline Characteristics

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Reporting Groups

	Description
Polyester Implants	There was one arm for this study. All subjects in this study received the investigational polyethylene terephthalate (PET) implants after enrollment in the original study. Subjects who could be reached and consented were enrolled in the long-term follow-up study, which was initiated to collect adverse events. See the detailed description for procedure information.

Baseline Measures

	Polyester Implants
Number of Participants [units: participants]	45
Age [units: years] Mean ± Standard Deviation
All subjects	45.0 ± 12.2
Gender [units: participants]
Female	23
Male	22
Race/Ethnicity, Customized [units: participants]
White	43
Hispanic	2

Outcome Measures

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1. Primary:

Functional Improvement [ Time Frame: 12 weeks after implantation ]

Measure Type	Primary
Measure Title	Functional Improvement
Measure 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
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
An implanted subject with missing data at 12 weeks of follow-up had the 6-week data carried forward to 12 weeks for analysis. If the 6-week data was unavailable, the subject's treatment was considered a failure.

Reporting Groups

	Description
Polyester Implants	There was one arm for this study. All subjects in this study received the investigational polyethylene terephthalate (PET) implants after enrollment in the original study. Subjects who could be reached and consented were enrolled in the long-term follow-up study, which was initiated to collect adverse events. See the detailed description for procedure information.

Measured Values

	Polyester Implants
Number of Participants Analyzed [units: participants]	45
Functional Improvement [units: participants]
≥ 30% reduction in NOSE score	40
≥ 10% increase in volume deflection (Vectra 3D)	30
≥ 30% NOSE reduction and ≥ 10% Vectra 3D increase	26

Statistical Analysis 1 for Functional Improvement

Groups ^[1]	Polyester Implants
Method ^[2]	One-sided, binomial exact test
P Value ^[3]	0.19
Percent of subjects with improvement ^[4]	57.8

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	This study had two independent primary endpoints (cosmetic and functional improvement). Therefore, the assumed type I error rate for each was 2.5% in order to maintain an overall 5% type I error rate. For each endpoint, the percent of subjects with improvement of the total number implanted was to be compared to a rate of 50% using a one-sided, binomial exact test. If the p-value was < 0.025, the objective would have been met.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
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[4]	Other relevant estimation information:
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2. Primary:

Cosmetic Improvement [ Time Frame: 12 weeks after implantation ]

Measure Type	Primary
Measure Title	Cosmetic Improvement
Measure 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
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
An implanted subject with missing data at 12 weeks of follow-up had the 6-week data carried forward to 12 weeks for analysis. If the 6-week data was unavailable, the subject's treatment was considered a failure.

Reporting Groups

	Description
Polyester Implants	There was one arm for this study. All subjects in this study received the investigational polyethylene terephthalate (PET) implants after enrollment in the original study. Subjects who could be reached and consented were enrolled in the long-term follow-up study, which was initiated to collect adverse events. See the detailed description for procedure information.

Measured Values

	Polyester Implants
Number of Participants Analyzed [units: participants]	45
Cosmetic Improvement [units: participants]
Order of photos: Could not evaluate	11
GAIS: Worse (After correct order ID)	4
GAIS: No change (After correct order ID)	15
GAIS: Improved (After correct order ID)	7
GAIS: Much improved (After correct order ID)	0
GAIS: Very much improved (After correct order ID)	0
GAIS: Could not evaluate (After correct order ID)	0
GAIS: Worse (After incorrect order ID)	8

Statistical Analysis 1 for Cosmetic Improvement

Groups ^[1]	Polyester Implants
Method ^[2]	One-sided, binomial exact test
P Value ^[3]	>0.99
Percent of subjects with improvement ^[4]	15.6

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[4]	Other relevant estimation information:
	No text entered.

3. Primary:

Safety [ Time Frame: During 12-week original study and at long-term follow-up of 11 months or longer ]

Measure Type	Primary
Measure Title	Safety
Measure 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
Safety Issue	Yes

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All enrolled subjects' adverse events were collected.

Reporting Groups

	Description
Polyester Implants	There was one arm for this study. All subjects in this study received the investigational polyethylene terephthalate (PET) implants after enrollment in the original study. Subjects who could be reached and consented were enrolled in the long-term follow-up study, which was initiated to collect adverse events. See the detailed description for procedure information.

Measured Values

	Polyester Implants
Number of Participants Analyzed [units: participants]	45
Safety [units: events]
Temporary pain implant site	39
Partial extrusion	17
Foreign body sensation	11
Upper respiratory infection/viral cold	8
Cosmetic contour deformity	7
Swelling/edema	7
Minimal bleeding	4
Cellulitis	3
Fever	2
Redness of skin	2
Tenderness	2
Vestibulitis	2
Sinus infection	2
Vomiting	2
Full extrusion	1
Infection	1
Bronchitis	1
Ecchymosis right cheek	1
Halitosis dysgusia	1
Herniated disc	1
Intranasal irritation/crust	1
Mild bruising perinasal	1
Numbness to tip of nose	1
Post inflammatory neuralgia	1
Pustule w/ implant exposure	1
Surface irritation sensation	1
Scarring	1

No statistical analysis provided for Safety

Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: David Hodge, Project Manager
Organization: Medtronic Xomed, Inc.
phone: (+1-904) 281-2774
e-mail: david.l.hodge@medtronic.com

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.

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.

Responsible Party:	Medtronic Xomed, Inc.
ClinicalTrials.gov Identifier:	NCT00729781 History of Changes
Other Study ID Numbers:	925
Study First Received:	August 5, 2008
Results First Received:	August 23, 2011
Last Updated:	December 1, 2011
Health Authority:	United States: Food and Drug Administration