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Evaluation of long-term (5-year) quality of life after nasal airway obstruction treatment with the Aerin Vivaer Stylus
This is a prospective, non-randomized, multi-center follow-up study to collect long term quality of life (QOL) data on a cohort of patients who participated in the Aerin Medical TP258 study "A Prospective, Multi-Center, Non-Randomized Study to Evaluate Treatment of Nasal Airway Obstruction Using the Aerin Medical Device". The TP258 study followed subjects out to 26 weeks post-procedure. This QOL study will collect data at 12, 18, 24, 36, 48 and 60 months post-procedure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Long-Term Study Subjects | This cohort will consist of all subjects who were treated with the Vivaer Stylus in the 50-subject TP258 interventional study, who consent to continue to provide quality of life data. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vivaer Stylus | Device | Previous nasal obstruction treatment with the Aerin Medical Vivaer Stylus |
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| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline NOSE Score | Mean change in Nasal Obstruction Symptom Evaluation (NOSE) score from baseline. The NOSE scale ranges from 0 to 100, so a maximum change from baseline would be 100 points. A positive number reported for the change from baseline indicates an improved outcome. | Baseline, 12, 18, 24 months post-procedure |
| Change From Baseline NOSE Score - Long Term Extended Follow-up | Mean change in Nasal Obstruction Symptom Evaluation (NOSE) score from baseline. The NOSE scale ranges from 0 to 100, so a maximum change from baseline would be 100 points. A positive number reported for the change from baseline indicates an improved outcome. | Update to include Extended Follow up to 36-, 48- months post-procedure |
| Number and Percentage of Participants With Positive Response on Quality of Life Assessment Items | This 21-item QOL scale was developed by Aerin Medical for this study to assess durability of symptom relief after treatment for nasal obstruction. Each item had 5 possible answers to convey the following responses: very positive, positive, neutral, negative and very negative. For questions 1-14, those who answered "agree or agree strongly" when prompted with "Compared to before I had the Aerin Medical Nasal Procedure, I have experienced..." were considered to have a positive response. For questions 15-18, those who answered "rarely/very rarely/never" when prompted with "Compared to before you had the procedure, how often did you suffer from the following conditions?..." were considered to have a positive response. For questions 19-21, those who answered "less or much less frequently" when prompted with "Compared to the time prior procedure, how often have you used the following to help you with nasal congestion/difficulty breathing?..." were considered to have a positive response. | 12, 18, 24 months post-procedure |
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Inclusion Criteria:
Exclusion Criteria:
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The subjects in this study will all have completed participation in the TP 258 Nasal Obstruction study.
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| Name | Affiliation | Role |
|---|---|---|
| Scott Wolf, MD | Aerin Medical | Study Director |
| Ofer Jacobowitz, MD, PhD | ENT and Allergy Associates, Middletown, NY | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Central California Clinical Research | Fresno | California | 93720 | United States | ||
| Colorado ENT and Allergy |
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| ID | Title | Description |
|---|---|---|
| FG000 | Long-Term Study Subjects | This cohort consisted of subjects who were treated with the Vivaer Stylus in the 50-subject TP258 interventional study (NCT02914236), who consented to continue to provide quality of life data. Vivaer Stylus: Previous nasal obstruction treatment with the Aerin Medical Vivaer Stylus |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Long-Term Study Subjects | This cohort will consist of all subjects who were treated with the Vivaer Stylus in the 50-subject TP258 interventional study, who consent to continue to provide quality of life data. Vivaer Stylus: Previous nasal obstruction treatment with the Aerin Medical Vivaer Stylus |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline NOSE Score | Mean change in Nasal Obstruction Symptom Evaluation (NOSE) score from baseline. The NOSE scale ranges from 0 to 100, so a maximum change from baseline would be 100 points. A positive number reported for the change from baseline indicates an improved outcome. | The population evaluated at 12 months was 36, rather than the full 39 participants, since 3 subjects had not completed the consent process until after the 12-month post-procedure evaluation window. By the 24-month follow-up, 3 subjects had been lost to follow-up. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 12, 18, 24 months post-procedure |
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Between 1 and 2 years post-procedure
Physician's office communicated with the subject either in person or by phone at each follow-up point.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Long-Term Study Subjects | This cohort consisted of subjects who were treated with the Vivaer Stylus in the 50-subject TP258 interventional study, who consented to continue to provide quality of life data. Vivaer Stylus: Previous nasal obstruction treatment with the Aerin Medical Vivaer Stylus |
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use of a single-arm design without randomized control, no control of medication usage, and significant patient attrition relative to the primary study. Two nonparticipants were known to have undergone subsequent surgery for nasal obstruction and it is possible that the effectiveness declined in the extended follow-up nonparticipants, although participants and non-participants had similar baseline characteristics and both groups experienced robust NOSE score reductions at 6months.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Scott Wolf, M.D.; Chief Medical Officer | Aerin Medical, Inc. | 650-597-0111 | swolf@aerinmedical.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 25, 2018 | Jul 2, 2019 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 22, 2019 | Jul 2, 2019 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D015508 | Nasal Obstruction |
| ID | Term |
|---|---|
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D000402 | Airway Obstruction |
| D012131 | Respiratory Insufficiency |
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| Colorado Springs |
| Colorado |
| 80909 |
| United States |
| ENT and Allergy Associates, LLP | Oradell | New Jersey | 07649 | United States |
| ENT and Allergy Associates, LLP | Bayside | New York | 11360 | United States |
| ENT and Allergy Associates, LLP | Middletown | New York | 10941 | United States |
| ENT and Allergy Associates, LLP | New Hyde Park | New York | 11042 | United States |
| Piedmont Ear, Nose and Throat Associates | Winston-Salem | North Carolina | 27103 | United States |
| Ear, Nose and Throat Associates of Texas | McKinney | Texas | 75070 | United States |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Baseline NOSE Score | The Nasal Obstruction Symptom Evaluation (NOSE) scale is a validated disease-specific health status outcomes instrument, used to assess severity of nasal obstruction symptoms. Score ranges from 0 to 100. Higher scores indicate increases symptoms/symptom severity. Each subject's baseline score was recorded at the beginning of the previous study, TP258. | Mean | Standard Deviation | units on a scale |
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| 26-week NOSE Score (end of previous study) | The Nasal Obstruction Symptom Evaluation (NOSE) scale is a validated disease-specific health status outcomes instrument, used to assess severity of nasal obstruction symptoms. Score ranges from 0 to 100. Higher scores indicate increases symptoms/symptom severity. The 26-week NOSE Score was the last score recorded for each subject at the end of the previous study, TP258. | Mean | Standard Deviation | units on a scale |
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| Change in NOSE score from baseline to 26 weeks | The Nasal Obstruction Symptom Evaluation score is used to assess severity of nasal obstruction symptoms. The NOSE scale ranges from 0 to 100. A positive number reported for the change from baseline indicates an improved outcome. | Mean | Standard Deviation | units on a scale |
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| 26-week responder | A "responder" for the prior study, TP258, was defined as a subject having at least a 15-point improvement in NOSE score (NOSE score described previously). The 39 subjects enrolled in this extension study were categorized as responders or nonresponders based on the change in NOSE score between baseline and the final 26-week follow-up of the previous study. | Count of Participants | Participants |
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| OG001 | Long-Term Study Subjects - 18 Month Data | This cohort consisted of subjects who were treated with the Vivaer Stylus in the 50-subject TP258 interventional study, who consented to continue to provide quality of life data and provided data within the 18-month post-procedure window. |
| OG002 | Long-Term Study Subjects - 24 Month Data | This cohort consisted of subjects who were treated with the Vivaer Stylus in the 50-subject TP258 interventional study, who consented to continue to provide quality of life data and provided data within the 24-month post-procedure window. |
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| Primary | Change From Baseline NOSE Score - Long Term Extended Follow-up | Mean change in Nasal Obstruction Symptom Evaluation (NOSE) score from baseline. The NOSE scale ranges from 0 to 100, so a maximum change from baseline would be 100 points. A positive number reported for the change from baseline indicates an improved outcome. | Of the 49 patients in the initial study,39 agreed to participate in follow-up through 24 months. | Posted | Mean | Standard Deviation | score on a scale | Update to include Extended Follow up to 36-, 48- months post-procedure |
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| Primary | Number and Percentage of Participants With Positive Response on Quality of Life Assessment Items | This 21-item QOL scale was developed by Aerin Medical for this study to assess durability of symptom relief after treatment for nasal obstruction. Each item had 5 possible answers to convey the following responses: very positive, positive, neutral, negative and very negative. For questions 1-14, those who answered "agree or agree strongly" when prompted with "Compared to before I had the Aerin Medical Nasal Procedure, I have experienced..." were considered to have a positive response. For questions 15-18, those who answered "rarely/very rarely/never" when prompted with "Compared to before you had the procedure, how often did you suffer from the following conditions?..." were considered to have a positive response. For questions 19-21, those who answered "less or much less frequently" when prompted with "Compared to the time prior procedure, how often have you used the following to help you with nasal congestion/difficulty breathing?..." were considered to have a positive response. | Data missing for some questions not answered by subjects. | Posted | Count of Participants | Participants | 12, 18, 24 months post-procedure |
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| 0 |
| 39 |
| 0 |
| 39 |
| 0 |
| 39 |
First publication of study results shall be made in conjunction with the results from all clinical study centers participating in the multicenter study. If results of the multi-center study have not been published in full within 18 months after completion of the study, investigator shall be free to publish results. Investigator agrees to submit all proposed publications to the sponsor at least 60 days prior submission; the company has the right to comment.
| D012120 |
| Respiration Disorders |
| D010038 | Otorhinolaryngologic Diseases |
| Q2: Less waking up at night |
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| Q3: Better sleep throughout the night |
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| Q4: Waking up feeling rested |
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| Q5: Less fatigue during the day |
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| Q6: Increased productivity |
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| Q7: Increased energy |
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| Q8: Increased ability to focus |
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| Q9: Increased sense of overall well-being |
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| Q10: Less feelings of frustration |
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| Q11: Less feelings of sadness |
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| Q12: Less feelings of embarrassment |
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| Q13:Missing fewer activites with family/friends |
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| Q14: Missing fewer days at work |
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| Q15: Headaches |
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| Q16: Sinus infections |
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| Q17: Sore throat |
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| Q18: Post nasal drip |
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| Q19: Oral medications |
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| Q20: Nasal sprays |
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| Q21: Nasal breathing strips |
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