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. (part of Stryker) · 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.
Spirox, Inc. is the lead sponsor of 4 studies on the registry; none are open to participants now.
First submitted before Spirox, Inc. became part of Stryker.
Counted across the registry records on this site, refreshed daily.
Eligible participants are:
Participants are excluded for the following:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Ran from Apr 2014 to primary completion in Dec 2015, 20 months.
Results were first posted in Oct 2016, 10 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Nov 2018. You cannot join it, but the record below documents what was studied.
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