An interventional study of INEX nasal implant in Nasal Valve Collapse, sponsored by Spirox, Inc.. Completed at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-03-26.
Sponsored by Spirox, Inc. · Not applicable, Interventional, and Treatment
To evaluate the safety and feasibility of the INEX Nasal Implant in subjects with moderate to severe nasal valve collapse.
This study is a multicenter, nonrandomized, prospective exploratory study of the INEX Nasal Implant. The purpose of this study is to evaluate the safety and feasibility of the INEX Nasal Implant in subjects with moderate to severe nasal valve collapse.
Eligible participants are:
Participants are excluded for the following:
Bilateral or unilateral INEX nasal implants
Device: INEX nasal implant
Treatment group may receive unilateral or bilateral INEX nasal implants (maximum of 4, 2 per side)
Implant-related Adverse Events
Implant-related adverse events (such as implant retrievals, procedure-related hematoma/inflammation)
Time frame: 6 months
Breathing Capacity (NOSE Scores)
Nasal breathing capacity was assessed using the validated Nasal Obstruction Symptom Evaluation (NOSE) questionnaire. The NOSE score uses a 0-100 point scale to capture severity of nasal symptoms (congestion, obstruction, trouble breathing, sleeping, and exercise), with higher scores indicating more severe symptoms than lower scores. NOSE severity classes are defined as Mild (5-25), Moderate (30-50), Severe (55-75), and Extreme (80-100).
Time frame: At baseline and at 6, 12, and 24 months post implant
NOSE Responder Rate
Percent of participants meeting responder criteria. Responders are defined as participants with a reduction from baseline in 1 or more Nasal Obstruction Symptom Evaluation Score (NOSE) severity class or a 20% reduction in the NOSE score.
Time frame: At 6, 12, and 24 months post implant
| Milestone | Treatment Group |
|---|---|
| Started | 30 |
| 6 months | 30 |
| 12 months | 30 |
| 24 months | 25 |
| Completed | 25 |
| Not completed | 5 |
| Withdrew: Withdrawal by subject | 5 |
Implant-related adverse events (such as implant retrievals, procedure-related hematoma/inflammation)
| participants | Treatment Group |
|---|---|
| Implant-related Adverse Events | 5 |
Nasal breathing capacity was assessed using the validated Nasal Obstruction Symptom Evaluation (NOSE) questionnaire. The NOSE score uses a 0-100 point scale to capture severity of nasal symptoms (congestion, obstruction, trouble breathing, sleeping, and exercise), with higher scores indicating more severe symptoms than lower scores. NOSE severity classes are defined as Mild (5-25), Moderate (30-50), Severe (55-75), and Extreme (80-100).
| scores on a scale | Treatment Group |
|---|---|
| Baseline | 76.7 ± 14.8 |
| 6 Months | 33.3 ± 29.7 |
| 12 Months | 35.2 ± 29.2 |
| 24 Months | 32.0 ± 29.3 |
Percent of participants meeting responder criteria. Responders are defined as participants with a reduction from baseline in 1 or more Nasal Obstruction Symptom Evaluation Score (NOSE) severity class or a 20% reduction in the NOSE score.
| percentage of responders | Nasal Implant Group |
|---|---|
| 6 Months | 80.0 |
| 12 Months | 76.7 |
| 24 Months | 80.0 |
Collected over Through 24 months post implant. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Treatment Group | 0/30 (0%) | 5/30 (16.7%) | 10/30 (33.3%) |
| Event | Treatment Group |
|---|---|
| Nonsurgical implant retrievalInvestigations | 3/30 |
| Hernia Repair ProcedureSurgical and medical procedures | 1/30 |
| BronchitisRespiratory, thoracic and mediastinal disorders | 1/30 |
| Event | Treatment Group |
|---|---|
| RhinitisGeneral disorders | 3/30 |
| RhinorrheaGeneral disorders | 2/30 |
| HematomaSkin and subcutaneous tissue disorders | 1/30 |
| InflammationSkin and subcutaneous tissue disorders | 1/30 |
| Acute hypertensionVascular disorders | 1/30 |
| Injury by fallen treeSocial circumstances | 1/30 |
| VertigoGeneral disorders | 1/30 |
| HeadacheGeneral disorders | 1/30 |
| Normal Bleeding EpistaxisBlood and lymphatic system disorders | 1/30 |
| Age, Continuous(years) | Treatment Group |
|---|---|
| Mean | 51.1 ± 14.5 |
| Sex: Female, Male(Participants) | Treatment Group |
|---|---|
| Female | 12 |
| Male | 18 |
Plan to share: No
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Spirox, Inc.