Trial Outcomes & Findings for Study of Polyester Implants for the Treatment of External Nasal Valve Collapse (NVC) (NCT NCT00729781)
NCT ID: NCT00729781
Last Updated: 2012-01-06
Results Overview
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.
TERMINATED
PHASE1/PHASE2
45 participants
12 weeks after implantation
2012-01-06
Participant Flow
Participant milestones
| Measure |
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.
|
|---|---|
|
Original Study
STARTED
|
45
|
|
Original Study
COMPLETED
|
45
|
|
Original Study
NOT COMPLETED
|
0
|
|
Long-term Follow-up Study
STARTED
|
42
|
|
Long-term Follow-up Study
COMPLETED
|
42
|
|
Long-term Follow-up Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of Polyester Implants for the Treatment of External Nasal Valve Collapse (NVC)
Baseline characteristics by cohort
| Measure |
Polyester Implants
n=45 Participants
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.
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|---|---|
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Age Continuous
All subjects
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45.0 years
STANDARD_DEVIATION 12.2 • n=93 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
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22 Participants
n=93 Participants
|
|
Race/Ethnicity, Customized
White
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43 participants
n=93 Participants
|
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Race/Ethnicity, Customized
Hispanic
|
2 participants
n=93 Participants
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PRIMARY outcome
Timeframe: 12 weeks after implantationPopulation: 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.
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.
Outcome measures
| Measure |
Polyester Implants
n=45 Participants
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.
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|---|---|
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Functional Improvement
≥ 30% reduction in NOSE score
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40 participants
|
|
Functional Improvement
≥ 10% increase in volume deflection (Vectra 3D)
|
30 participants
|
|
Functional Improvement
≥ 30% NOSE reduction and ≥ 10% Vectra 3D increase
|
26 participants
|
PRIMARY outcome
Timeframe: 12 weeks after implantationPopulation: 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.
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.
Outcome measures
| Measure |
Polyester Implants
n=45 Participants
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.
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|---|---|
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Cosmetic Improvement
Order of photos: Could not evaluate
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11 participants
|
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Cosmetic Improvement
GAIS: Worse (After correct order ID)
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4 participants
|
|
Cosmetic Improvement
GAIS: No change (After correct order ID)
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15 participants
|
|
Cosmetic Improvement
GAIS: Improved (After correct order ID)
|
7 participants
|
|
Cosmetic Improvement
GAIS: Much improved (After correct order ID)
|
0 participants
|
|
Cosmetic Improvement
GAIS: Very much improved (After correct order ID)
|
0 participants
|
|
Cosmetic Improvement
GAIS: Could not evaluate (After correct order ID)
|
0 participants
|
|
Cosmetic Improvement
GAIS: Worse (After incorrect order ID)
|
8 participants
|
PRIMARY outcome
Timeframe: During 12-week original study and at long-term follow-up of 11 months or longerPopulation: All enrolled subjects' adverse events were collected.
Evaluate complications and adverse events. Events are presented descriptively with no statistical analysis.
Outcome measures
| Measure |
Polyester Implants
n=45 Participants
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.
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|---|---|
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Safety
Redness of skin
|
2 events
|
|
Safety
Tenderness
|
2 events
|
|
Safety
Vestibulitis
|
2 events
|
|
Safety
Temporary pain implant site
|
39 events
|
|
Safety
Partial extrusion
|
17 events
|
|
Safety
Foreign body sensation
|
11 events
|
|
Safety
Upper respiratory infection/viral cold
|
8 events
|
|
Safety
Cosmetic contour deformity
|
7 events
|
|
Safety
Swelling/edema
|
7 events
|
|
Safety
Minimal bleeding
|
4 events
|
|
Safety
Cellulitis
|
3 events
|
|
Safety
Fever
|
2 events
|
|
Safety
Sinus infection
|
2 events
|
|
Safety
Vomiting
|
2 events
|
|
Safety
Full extrusion
|
1 events
|
|
Safety
Infection
|
1 events
|
|
Safety
Bronchitis
|
1 events
|
|
Safety
Ecchymosis right cheek
|
1 events
|
|
Safety
Halitosis dysgusia
|
1 events
|
|
Safety
Herniated disc
|
1 events
|
|
Safety
Intranasal irritation/crust
|
1 events
|
|
Safety
Mild bruising perinasal
|
1 events
|
|
Safety
Numbness to tip of nose
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1 events
|
|
Safety
Post inflammatory neuralgia
|
1 events
|
|
Safety
Pustule w/ implant exposure
|
1 events
|
|
Safety
Surface irritation sensation
|
1 events
|
|
Safety
Scarring
|
1 events
|
Adverse Events
Polyester Implants
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Polyester Implants
n=45 participants at risk
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.
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|---|---|
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Skin and subcutaneous tissue disorders
Temporary pain implant site
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62.2%
28/45 • Number of events 39
|
|
Surgical and medical procedures
Partial extrusion
|
20.0%
9/45 • Number of events 17
|
|
Skin and subcutaneous tissue disorders
Foreign body sensation
|
24.4%
11/45 • Number of events 11
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory infection/viral cold
|
15.6%
7/45 • Number of events 8
|
|
Surgical and medical procedures
Cosmetic contour deformity
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13.3%
6/45 • Number of events 7
|
|
Skin and subcutaneous tissue disorders
Swelling/edema
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15.6%
7/45 • Number of events 7
|
|
Surgical and medical procedures
Minimal bleeding
|
6.7%
3/45 • Number of events 4
|
|
Skin and subcutaneous tissue disorders
Cellulitis
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6.7%
3/45 • Number of events 3
|
Additional Information
David Hodge, Project Manager
Medtronic Xomed, Inc.
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60