Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nasal implant group | Experimental | Bilateral or unilateral INEX nasal implants |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| INEX nasal implant | Device | Treatment group may receive unilateral or bilateral INEX nasal implants (maximum of 4, 2 per side) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Implant-related Adverse Events | Implant-related adverse events (such as implant retrievals, procedure-related hematoma/inflammation) | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
Not provided
Eligible participants are:
Participants are excluded for the following:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Alexander Berghaus, MD | Ludwig-Maximilians - University of Munich | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Klinik und Poliklinik für Hals-Nasen-Ohren-Heilkunde am Klinikum der LMU | Munich | 81377 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 14990910 | Background | Stewart MG, Witsell DL, Smith TL, Weaver EM, Yueh B, Hannley MT. Development and validation of the Nasal Obstruction Symptom Evaluation (NOSE) scale. Otolaryngol Head Neck Surg. 2004 Feb;130(2):157-63. doi: 10.1016/j.otohns.2003.09.016. | |
| 28388804 | Result | San Nicolo M, Stelter K, Sadick H, Bas M, Berghaus A. Absorbable Implant to Treat Nasal Valve Collapse. Facial Plast Surg. 2017 Apr;33(2):233-240. doi: 10.1055/s-0037-1598655. Epub 2017 Apr 7. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Treatment Group | Nasal implant: Treatment group may receive unilateral or bilateral nasal implants (maximum of 4, 2 per side) |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Treatment Group | Nasal implant: Treatment group may receive unilateral or bilateral nasal implants (maximum of 4, 2 per side) |
| Units | Counts |
|---|---|
| Participants |
|
| 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 | Implant-related Adverse Events | Implant-related adverse events (such as implant retrievals, procedure-related hematoma/inflammation) | Posted | Number | participants | 6 months |
|
|
Through 24 months post implant
Device extrusions/retrievals were counted as serious implant-related adverse events. Otherwise, the standard definition applies.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treatment Group | Nasal implant: Treatment group may receive unilateral or bilateral nasal implants (maximum of 4, 2 per side) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nonsurgical implant retrieval | Investigations | Systematic Assessment | 3/56 total implants placed were retrieved post implantation. Implant retrieval did not require surgical intervention and did not result in any adverse clinical sequelae. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hematoma | Skin and subcutaneous tissue disorders | Systematic Assessment | A non-serious device-related hematoma was observed. |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Principal Clinical Research & Publications Manager | Stryker ENT | 763-463-1598 | ellen.omalley@stryker.com |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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. | At 6, 12, and 24 months post implant |
| 30227454 | Result | San Nicolo M, Stelter K, Sadick H, Bas M, Berghaus A. A 2-Year Follow-up Study of an Absorbable Implant to Treat Nasal Valve Collapse. Facial Plast Surg. 2018 Oct;34(5):545-550. doi: 10.1055/s-0038-1672213. Epub 2018 Sep 18. |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
| Secondary | 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). | All 30 participants completed follow-up through 12 months. Five participants discontinued after the 12-month visit and before the 24-month visit. | Posted | Mean | Standard Deviation | scores on a scale | At baseline and at 6, 12, and 24 months post implant |
|
|
|
|
| Secondary | 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. | All 30 participants completed follow-up through 12 months. Five participants discontinued after the 12-month visit and before the 24-month visit. | Posted | Number | percentage of responders | At 6, 12, and 24 months post implant |
|
|
|
| 0 |
| 30 |
| 5 |
| 30 |
| 10 |
| 30 |
|
| Hernia Repair Procedure | Surgical and medical procedures | Systematic Assessment | Hernia repair procedure occurred during the follow-up period and was not related to the investigational device or the nasal implant procedure. |
|
| Bronchitis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Bronchitis occurred during the follow-up period and was not related to the investigational device or the nasal implant procedure. |
|
|
| Inflammation | Skin and subcutaneous tissue disorders | Systematic Assessment | A non-serious device-related observation of inflammation was reported. |
|
| Rhinitis | General disorders | Systematic Assessment | Includes reports of rhinitis and "common cold", non-serious and not device-related |
|
| Rhinorrhea | General disorders | Systematic Assessment | Non-serious and not device-related |
|
| Acute hypertension | Vascular disorders | Systematic Assessment | Non-serious and not device-related |
|
| Injury by fallen tree | Social circumstances | Systematic Assessment | Non-serious and not device-related |
|
| Vertigo | General disorders | Systematic Assessment | Non-serious and not device-related |
|
| Headache | General disorders | Systematic Assessment | Non serious and not device-related |
|
| Normal Bleeding Epistaxis | Blood and lymphatic system disorders | Systematic Assessment | Normal bleeding epistaxis occurred during the follow-up period and was not related to the investigational device or the nasal implant procedure. |
|
Not provided
Not provided
|
| 12 Months |
|
|
| 24 Months |
|
|
|
| 24 Months |
|
|