Nasal Valve Collapse
Conditions
Brief summary
To evaluate the safety and feasibility of the INEX Nasal Implant in subjects with moderate to severe nasal valve collapse.
Detailed description
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.
Interventions
DEVICEINEX nasal implant
Treatment group may receive unilateral or bilateral INEX nasal implants (maximum of 4, 2 per side)
Sponsors
Spirox, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Eligible participants are: 1. Adult patients seeking treatment for nasal obstruction on one or both sides of the nose who are willing to undergo an office-based or intraoperative nasal implant procedure in lieu of alternative treatments (ie, surgical repair or use of an external dilator). 2. Nasal valve collapse (NVC) must be a primary or significant contributor to the subject's nasal obstruction based on clinical presentation, physical examination and nasal endoscopy. 3. Baseline Nasal Obstruction Symptom Evaluation (NOSE) score must be ≥55. Participants are excluded for the following: 1. Surgical or non-surgical treatment of the nasal valve or rhinoplasty within 12 months before enrollment. 2. Septoplasty, inferior turbinate reduction, or other surgical nasal procedures within 6 months before enrollment. 3. Recurrent nasal infections. 4. Use of intranasal steroids within 2 weeks preimplant and 2 weeks post implantation. 5. Presence of a permanent implant, dilator, or uses an external device in the nasal area. 6. Cancerous or precancerous lesions and/or radiation exposure in the treatment area or chemotherapy within 24 months of the study. 7. Significant bleeding disorders. 8. Significant systemic diseases. 9. Currently using nasal oxygen or continuous positive airway pressure (CPAP).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Implant-related Adverse Events | 6 months | Implant-related adverse events (such as implant retrievals, procedure-related hematoma/inflammation) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Breathing Capacity (NOSE Scores) | At baseline and at 6, 12, and 24 months post implant | 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). |
| NOSE Responder Rate | At 6, 12, and 24 months post implant | 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. |
Countries
Germany
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Treatment Group Nasal implant: Treatment group may receive unilateral or bilateral nasal implants (maximum of 4, 2 per side) | 30 |
| Total | 30 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 5 |
Baseline characteristics
| Characteristic | Treatment Group |
|---|---|
| Age, Continuous | 51.1 years STANDARD_DEVIATION 14.5 |
| Sex: Female, Male Female | 12 Participants |
| Sex: Female, Male Male | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 30 |
| other Total, other adverse events | 10 / 30 |
| serious Total, serious adverse events | 5 / 30 |
Outcome results
Primary
Implant-related Adverse Events
Implant-related adverse events (such as implant retrievals, procedure-related hematoma/inflammation)
Time frame: 6 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment Group | Implant-related Adverse Events | 5 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).
Time frame: At baseline and at 6, 12, and 24 months post implant
Population: All 30 participants completed follow-up through 12 months. Five participants discontinued after the 12-month visit and before the 24-month visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment Group | Breathing Capacity (NOSE Scores) | Baseline | 76.7 scores on a scale | Standard Deviation 14.8 |
| Treatment Group | Breathing Capacity (NOSE Scores) | 6 Months | 33.3 scores on a scale | Standard Deviation 29.7 |
| Treatment Group | Breathing Capacity (NOSE Scores) | 12 Months | 35.2 scores on a scale | Standard Deviation 29.2 |
| Treatment Group | Breathing Capacity (NOSE Scores) | 24 Months | 32.0 scores on a scale | Standard Deviation 29.3 |
p-value: <0.001t-test, 2 sided
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.
Time frame: At 6, 12, and 24 months post implant
Population: All 30 participants completed follow-up through 12 months. Five participants discontinued after the 12-month visit and before the 24-month visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Treatment Group | NOSE Responder Rate | 6 Months | 80.0 percentage of responders |
| Treatment Group | NOSE Responder Rate | 12 Months | 76.7 percentage of responders |
| Treatment Group | NOSE Responder Rate | 24 Months | 80.0 percentage of responders |