An observational study in Nasal Obstruction, sponsored by Aerin Medical. Completed at 8 sites in United States. Open to participants aged 22 Years and older. Per ClinicalTrials.gov, last updated 2024-02-15.
Sponsored by Aerin Medical · Observational
Among 10 studies in Nasal Obstruction by Aerin Medical — 1 open to participants now, 2 under way, none of them phase 3. Nasal Obstruction · Aerin Medical.
Among the 10 studies in Nasal Obstruction by Aerin Medical, this one is one of 2 that started in 2017, is one of 3 observational ones, and was the 4th registered.
173 studies on the registry are indexed under Nasal Obstruction; 31 are open to participants now.
Browse Nasal Obstruction studies →1 of the 10 studies in Nasal Obstruction by Aerin Medical is open now, in 1 country. Recruiting first, the newest first:
Aerin Medical · Sites in United States
Ages 22–85
By country, each count listing its studies:
Of the 20 Nasal Obstruction studies recruiting now, 7 (35%) set no upper age limit and 11 (55%) stop at 75 or younger; 4 take children under 18; 4 take healthy volunteers.
This study: 22 Years and older · all sexes · no healthy volunteers.
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10 studies; the count open now beside each. This study's row is marked.
First in 2013; this study’s year is marked. 2 started in 2017.
This study's enrollment of 39 is below the median of 80 across 25 observational studies indexed under Nasal Obstruction.
Median enrollment 50 across the 7 interventional studies, 400 across the 3 observational. Of the 8 that completed or were terminated, 7 (88%) have results posted.
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Aerin Medical is the lead sponsor of 15 studies on the registry; 1 is open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 7 (88%) have results posted.
1 of the studies in Nasal Obstruction by Aerin Medical that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07574918Aerin MedicalMeasuring Nasal Airway Changes After VivAer Treatment Using AI Analysis | 2027-05 |
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Among the 10 studies in Nasal Obstruction by Aerin Medical, from their registry updates:
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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.
The subjects in this study will all have completed participation in the TP 258 Nasal Obstruction study.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
Device: Vivaer Stylus
Previous nasal obstruction treatment with the Aerin Medical Vivaer Stylus
Also known as: Aerin Medical Device
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.
Time frame: 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.
Time frame: 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.
Time frame: 12, 18, 24 months post-procedure
| Milestone | Long-Term Study Subjects |
|---|---|
| Started | 39 |
| Completed | 36 |
| Not completed | 3 |
| Withdrew: Lost to follow-up | 3 |
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.
| units on a scale | Long-Term Study Subjects - 12 Month Data | Long-Term Study Subjects - 18 Month Data | Long-Term Study Subjects - 24 Month Data |
|---|---|---|---|
| Change From Baseline NOSE Score | 53.3 ± 25.2 | 48.1 ± 30.2 | 53.5 ± 24.6 |
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.
| score on a scale | 36 Month | Long-Term Study Subjects - 48 Month Data |
|---|---|---|
| Change From Baseline NOSE Score - Long Term Extended Follow-up | 32.3 ± 21.4 | 25.7 ± 19.1 |
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.
| Participants | Long-Term Study Subjects - 12 Month | Long-Term Study Subjects - 18 Month Data | Long-Term Study Subjects - 24 Month Data |
|---|---|---|---|
| Q1: Less difficulty falling asleep | 25 | 22 | 28 |
| Q2: Less waking up at night | 20 | 25 | 25 |
| Q3: Better sleep throughout the night | 23 | 27 | 26 |
| Q4: Waking up feeling rested | 18 | 21 | 22 |
| Q5: Less fatigue during the day | 20 | 24 | 19 |
| Q6: Increased productivity | 13 | 16 | 21 |
| Q7: Increased energy | 18 | 16 | 22 |
| Q8: Increased ability to focus | 11 | 18 | 22 |
| Q9: Increased sense of overall well-being | 18 | 21 | 23 |
| Q10: Less feelings of frustration | 17 | 21 | 18 |
| Q11: Less feelings of sadness | 12 | 13 | 17 |
| Q12: Less feelings of embarrassment | 20 | 13 | 16 |
| Q13:Missing fewer activites with family/friends | 12 | 13 | 17 |
| Q14: Missing fewer days at work | 9 | 8 | 15 |
| Q15: Headaches | 22 | 27 | 28 |
| Q16: Sinus infections | 28 | 32 | 33 |
| Q17: Sore throat | 30 | 33 | 30 |
| Q18: Post nasal drip | 19 | 19 | 21 |
| Q19: Oral medications | 23 | 19 | 24 |
| Q20: Nasal sprays | 26 | 20 | 23 |
| Q21: Nasal breathing strips | 22 | 27 | 29 |
Collected over Between 1 and 2 years post-procedure. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Long-Term Study Subjects | 0/39 (0%) | 0/39 (0%) | 0/39 (0%) |
| Age, Continuous(years) | Long-Term Study Subjects |
|---|---|
| Mean | 51.7 ± 12.8 |
| Sex: Female, Male(Participants) | Long-Term Study Subjects |
|---|---|
| Female | 20 |
| Male | 19 |
| Ethnicity (NIH/OMB)(Participants) | Long-Term Study Subjects |
|---|---|
| Hispanic or Latino | 2 |
| Not Hispanic or Latino | 37 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Long-Term Study Subjects |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 39 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | Long-Term Study Subjects |
|---|---|
| United States | 39 |
| Baseline NOSE Score(units on a scale) | Long-Term Study Subjects |
|---|---|
| Mean | 80.8 ± 10.7 |
| 26-week NOSE Score (end of previous study)(units on a scale) | Long-Term Study Subjects |
|---|---|
| Mean | 24.9 ± 21.3 |
| Change in NOSE score from baseline to 26 weeks(units on a scale) | Long-Term Study Subjects |
|---|---|
| Mean | 55.9 ± 23.6 |
1 further baseline measures are reported on the registry.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Oct 2017 to primary completion in Jul 2022, 56 months.
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This study is completed, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.
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