Nasal Obstruction
Conditions
Keywords
nasal valve collapse, absorbable nasal implant
Brief summary
Prospective, multicenter, nonrandomized, single-arm controlled study to obtain outcomes data in participants with severe to extreme class NOSE scores who are undergoing placement of the Spirox Latera Implant with or without concurrent turbinate reduction procedures in an office setting.
Interventions
DEVICENasal Implant
Latera implant placed as a standalone procedure or in conjunction with a turbinate reduction procedure in an office setting under local anesthesia.
Sponsors
New Arch Consulting
Spirox, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Single-arm intervention with pre/post comparison for treatment response.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. The subject has Nasal Obstruction Symptom Evaluation (NOSE) score ≥55. 2. The subject has dynamic lateral nasal wall insufficiency as confirmed by positive modified Cottle maneuver. 3. The subject is ≥18 years of age. 4. The subject is willing and able to provide informed consent and comply with the study protocol. 5. The subject is seeking treatment for nasal airway obstruction due to nasal valve collapse (NVC) and is willing to undergo an in-office nasal implant procedure alone or with a turbinate reduction procedure. 6. The subject has appropriate nasal and facial anatomy to receive the Latera Implant. 7. The subject agrees to follow-up examinations through 12 months post operatively. 8. The subject has failed to benefit from appropriate maximal medical management \[eg, nasal steroids (at least 4 weeks); antihistamines; oral decongestants; nasal strips, stents, or cones\]. Failure of maximal medical management may be from lack of effectiveness or tolerability.
Exclusion criteria
1. The subject is having a concurrent functional endoscopic sinus surgery (FESS) or sinuplasty. 2. The subject has had rhinoplasty within the past 12 months. 3. The subject is planning to have other concurrent rhinoplasty procedure. 4. The subject is planning to have other rhinoplasty procedures or will use external dilators within 12 months after the index procedure. 5. The subject has had septoplasty and/or inferior turbinate reduction within the past 6 months. 6. The subject has, in the view of the clinician, inappropriate fixation on their nasal airway. 7. The subject plans to have any surgical or nonsurgical treatment of their nasal valve, other than the index procedure, within 12 months of the study. 8. The subject has a permanent Implant or dilator in the nasal area. 9. The subject has concomitant inflammatory or infectious skin conditions or unhealed wounds in the treatment area. 10. The subject currently has active nasal vestibulitis. 11. The subject has a history of nasal vasculitis. 12. The subject is a chronic systemic steroid or recreational intranasal drug user. 13. The subject has had a cancerous or precancerous lesion and/or has had radiation exposure in the treatment area or chemotherapy. 14. The subject has polyps or pathology (ie, septal deviation) other than turbinate hypertrophy and/or lateral wall insufficiency that would contribute to airway obstruction. 15. The subject has a history of a significant bleeding disorder(s) that would prevent healing of the treatment area post procedure. 16. The subject has a known or suspected allergy to polylactide polymer (PLA) or other absorbable materials. 17. The subject has a significant systemic disease such as poorly controlled diabetes which, in the investigator's opinion, could predispose the subject to poor wound healing. 18. The subject is currently using nasal oxygen or continuous positive airway pressure (CPAP). 19. The subject is not a candidate for procedures conducted under local anesthesia and/or managed anesthesia care (MAC) or conscious sedation. 20. Female subjects of childbearing potential, known or suspected to be pregnant, or is lactating.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy: Percent of Treatment Responders | 6 months | A responder is defined as a participant who has an improvement of at least 1 NOSE class or a NOSE score reduction of at least 20% compared with baseline. NOSE scores can range from 0 to 100 with higher scores indicating worse symptoms. Classes are mild (5-25), moderate (30-50), severe (55-75) and extreme (80-100). |
| Safety: Procedure- and/or Device-related Adverse Events | 6 months | Number of participants with 1 or more adverse events that are determined to be related to the Latera implant and/or procedure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent of Treatment Responders | 1, 3, 12, 18, and 24 months post procedure. | A responder is defined as a participant who has an improvement of at least 1 NOSE class or a NOSE score reduction of at least 20% compared with baseline. NOSE scores can range from 0 to 100 with higher scores indicating worse symptoms. Classes are mild (5-25), moderate (30-50), severe (55-75) and extreme (80-100). |
| Change in Nasal Airway Obstruction From Baseline Using a Visual Analog Scale (VAS) | 1, 3, 6, 12, 18, and 24 months post procedure | Change from baseline in the nasal obstryction VAS score. Participants provide scores on a scale of 0 (easy to breathe through the nose) to 100 (difficult to breathe through the nose) using a 100-mm line with 1-mm increments). Negative values indicate improvement in symptoms. |
| Subject Satisfaction Questionnaire | 6 months | Participants rate whether they are satisfied or not satisfied with the procedure and cosmetic appearance after the procedure. The percent of participants reporting satisfaction with the procedure is reported. |
| Procedure and Device-related Adverse Events | After 6 months and up to 12 months post procedure | Number of participants who experience procedure- or device-related adverse events. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Latera Implant Nasal Implant
Nasal Implant: Latera implant will be placed in stand alone procedure or in conjunction with a turbinate reduction procedure | 166 |
| Total | 166 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 1 |
| Overall Study | Did not consent to long-term FU | 14 |
| Overall Study | Lack of Efficacy | 10 |
| Overall Study | Lost to Follow-up | 28 |
| Overall Study | Withdrawal by Subject | 11 |
Baseline characteristics
| Characteristic | Latera Implant |
|---|---|
| Age, Continuous | 50.5 years STANDARD_DEVIATION 14.9 |
| Nasal Obstruction Visual Analog Scale (VAS) | 68.0 units on a scale STANDARD_DEVIATION 18 |
| NOSE score (100-point scale) | 77.4 units on a scale STANDARD_DEVIATION 13.4 |
| Nose Severity Class Extreme | 76 Participants |
| Nose Severity Class Severe | 90 Participants |
| Race/Ethnicity, Customized Race American Indian or Alaska Native | 1 Participants |
| Race/Ethnicity, Customized Race Asian | 3 Participants |
| Race/Ethnicity, Customized Race Black or African American | 3 Participants |
| Race/Ethnicity, Customized Race Hispanic or Latino | 11 Participants |
| Race/Ethnicity, Customized Race Not Specified | 1 Participants |
| Race/Ethnicity, Customized Race Other | 4 Participants |
| Race/Ethnicity, Customized Race White | 143 Participants |
| Region of Enrollment United States | 166 participants |
| Sex: Female, Male Female | 82 Participants |
| Sex: Female, Male Male | 84 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 166 |
| other Total, other adverse events | 24 / 166 |
| serious Total, serious adverse events | 0 / 166 |
Outcome results
Primary
Efficacy: Percent of Treatment Responders
A responder is defined as a participant who has an improvement of at least 1 NOSE class or a NOSE score reduction of at least 20% compared with baseline. NOSE scores can range from 0 to 100 with higher scores indicating worse symptoms. Classes are mild (5-25), moderate (30-50), severe (55-75) and extreme (80-100).
Time frame: 6 months
Population: All participants who had placement of 1 or more Latera implants and had a 6-month NOSE score.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Latera Implant | Efficacy: Percent of Treatment Responders | 136 Participants |
Comparison: The null hypothesis was that the proportion of responders at 6 months would be 50%. Since there was not direct comparison group, the hypothesis was set as a superiority comparison to a target proportion (66%) with a power level \>90%.95% CI: [83.5, 93.9]
Primary
Safety: Procedure- and/or Device-related Adverse Events
Number of participants with 1 or more adverse events that are determined to be related to the Latera implant and/or procedure.
Time frame: 6 months
Population: All participants who received 1 or more Latera implants.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Latera Implant | Safety: Procedure- and/or Device-related Adverse Events | 31 Participants |
Secondary
Change in Nasal Airway Obstruction From Baseline Using a Visual Analog Scale (VAS)
Change from baseline in the nasal obstryction VAS score. Participants provide scores on a scale of 0 (easy to breathe through the nose) to 100 (difficult to breathe through the nose) using a 100-mm line with 1-mm increments). Negative values indicate improvement in symptoms.
Time frame: 1, 3, 6, 12, 18, and 24 months post procedure
Population: All participants with VAS scores at the applicable visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Latera Implant | Change in Nasal Airway Obstruction From Baseline Using a Visual Analog Scale (VAS) | 1-Month Follow-up | -34.3 score on a scale | Standard Deviation 27 |
| Latera Implant | Change in Nasal Airway Obstruction From Baseline Using a Visual Analog Scale (VAS) | 3-Month Follow-up | -35.5 score on a scale | Standard Deviation 28.5 |
| Latera Implant | Change in Nasal Airway Obstruction From Baseline Using a Visual Analog Scale (VAS) | 6-Month Follow-up | -36.9 score on a scale | Standard Deviation 29 |
| Latera Implant | Change in Nasal Airway Obstruction From Baseline Using a Visual Analog Scale (VAS) | 12-Month Follow-up | -37.9 score on a scale | Standard Deviation 29.8 |
| Latera Implant | Change in Nasal Airway Obstruction From Baseline Using a Visual Analog Scale (VAS) | 18-Month Follow-up | -41.5 score on a scale | Standard Deviation 27.3 |
| Latera Implant | Change in Nasal Airway Obstruction From Baseline Using a Visual Analog Scale (VAS) | 24-Month Follow-up | -41.7 score on a scale | Standard Deviation 26.8 |
p-value: <0.001t-test, 2 sided
Secondary
Percent of Treatment Responders
A responder is defined as a participant who has an improvement of at least 1 NOSE class or a NOSE score reduction of at least 20% compared with baseline. NOSE scores can range from 0 to 100 with higher scores indicating worse symptoms. Classes are mild (5-25), moderate (30-50), severe (55-75) and extreme (80-100).
Time frame: 1, 3, 12, 18, and 24 months post procedure.
Population: All participants with NOSE scores at the applicable visit.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Latera Implant | Percent of Treatment Responders | 1-Month Follow-up | 147 Participants |
| Latera Implant | Percent of Treatment Responders | 3-Month Follow-up | 143 Participants |
| Latera Implant | Percent of Treatment Responders | 12-Month Follow-up | 124 Participants |
| Latera Implant | Percent of Treatment Responders | 18-Month Follow-up | 103 Participants |
| Latera Implant | Percent of Treatment Responders | 24-Month Follow-up | 93 Participants |
Secondary
Procedure and Device-related Adverse Events
Number of participants who experience procedure- or device-related adverse events.
Time frame: After 6 months and up to 12 months post procedure
Population: All participants with greater than 6-months follow-up.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Latera Implant | Procedure and Device-related Adverse Events | 3 Participants |
Secondary
Subject Satisfaction Questionnaire
Participants rate whether they are satisfied or not satisfied with the procedure and cosmetic appearance after the procedure. The percent of participants reporting satisfaction with the procedure is reported.
Time frame: 6 months
Population: All participants who completed a satisfaction questionnaire at the 6-month visit.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Latera Implant | Subject Satisfaction Questionnaire | 115 Participants |