Nasal Obstruction
Conditions
Brief summary
This study is being conducted to obtain outcomes data in subjects with severe to extreme class NOSE scores undergoing placement of the Spirox Latera Implant with or without concurrent septoplasty and/or turbinate reduction procedures in an operating room setting.
Interventions
DEVICENasal Implant
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
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 Maneuver22. 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 nasal Implant procedure alone or with septoplasty and/or a turbinate reduction procedure in an operating room setting. 6. The subject has appropriate nasal and facial anatomy to receive Latera Implant. 7. The subject agrees to follow-up examinations through twelve (12) months post operatively. 8. The subject has failed a trial of appropriate maximal medical management \[e.g., nasal steroids (at least 4 weeks); antihistamines; oral decongestants; nasal strips, stents, or cones\]. Failure of maximal medical management may be from lack of effectiveness or inability of subject to tolerate.
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 twelve (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 twelve (12) months after the index procedure. 5. The subject has had septoplasty and/or inferior turbinate reduction within the past six (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 non-surgical treatment of their nasal valve, other than the index procedure, within twelve (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 intra-nasal drug user. 13. The subject has had a cancerous or pre-cancerous lesion and/or has had radiation exposure in the treatment area or chemotherapy. 14. The subject has polyps or pathology other than septal deviation and/or 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 poly lactic acid (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 pre-dispose 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 general anesthesia, managed anesthesia care (MAC) or conscious sedation. 20. If female, subject is known or suspected to be pregnant or is lactating.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Primary Efficacy Endpoint is the Percent of Treatment Responders | 6 months post procedure | Responder is defined as a participant who has improvement of at least 1 Nasal Obstruction Symptom Evaluation (NOSE) class or at least 20% NOSE score reduction. NOSE scores. NOSE scores can range from 5 to 100, with higher scores indicating worse symptoms. Classes are mild (5-25), moderate (30-50), severe (55-75), and severe (80-100). |
| Primary Safety Endpoint: Nasal Procedure and Latera™ Device-related Adverse Events | 6 months post procedure | Number of participants with a device-related or procedure-related adverse event |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent of Treatment Responders | 1, 3 12, 18, and 24 months post procedure. | Responder is defined as a participant who has improvement of at least 1 Nasal Obstruction Symptom Evaluation (NOSE) class or at least 20% NOSE score reduction. NOSE scores. NOSE scores can range from 5 to 100, with higher scores indicating worse symptoms. Classes are mild (5-25), moderate (30-50), severe (55-75), and severe (80-100). |
| Change in Nasal Airway Obstruction From Baseline Using the Visual Analog Scale (VAS). | 1, 3, 6, 12, 18, and 24 months post procedure | Change from baseline in VAS score for ability to breathe through the nose. Participants provide scores on a scale of 0 (easy to breathe through the nose) to 100 (unable to breathe through the nose). Negative values for the change from baseline 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 24 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 All participants have unilateral or bilateral placement of LATERA Nasal Implants.
Nasal Implant | 113 |
| Total | 113 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Long-term Follow-up | Death | 1 |
| Long-term Follow-up | Did not reconsent for long-term FU | 7 |
| Long-term Follow-up | Lack of Efficacy | 6 |
| Long-term Follow-up | Lost to Follow-up | 12 |
| Long-term Follow-up | Physician Decision | 1 |
| Long-term Follow-up | Withdrawal by Subject | 5 |
| Primary Endpoint | Lack of Efficacy | 1 |
| Primary Endpoint | Lost to Follow-up | 4 |
| Primary Endpoint | Missed visit | 1 |
| Primary Endpoint | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Latera Implant |
|---|---|
| Age, Continuous | 45.3 years STANDARD_DEVIATION 13.7 |
| NOSE Score (100-point scale) | 78.5 units on a scale STANDARD_DEVIATION 13.8 |
| NOSE Severity Classification Extreme (Nose Scores of 80-100 | 57 Participants |
| NOSE Severity Classification Severe (NOSE Scores of 55-75) | 56 Participants |
| Race/Ethnicity, Customized Ethnicity Hispanic or Latino | 10 Participants |
| Race/Ethnicity, Customized Ethnicity Non-Hispanic or Latino | 102 Participants |
| Race/Ethnicity, Customized Ethnicity Unspecified | 1 Participants |
| Region of Enrollment United States | 113 Participants |
| Sex: Female, Male Female | 49 Participants |
| Sex: Female, Male Male | 64 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 113 |
| other Total, other adverse events | 19 / 113 |
| serious Total, serious adverse events | 2 / 113 |
Outcome results
Primary
Primary Safety Endpoint: Nasal Procedure and Latera™ Device-related Adverse Events
Number of participants with a device-related or procedure-related adverse event
Time frame: 6 months post procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Latera Implant | Primary Safety Endpoint: Nasal Procedure and Latera™ Device-related Adverse Events | 10 Participants |
Primary
The Primary Efficacy Endpoint is the Percent of Treatment Responders
Responder is defined as a participant who has improvement of at least 1 Nasal Obstruction Symptom Evaluation (NOSE) class or at least 20% NOSE score reduction. NOSE scores. NOSE scores can range from 5 to 100, with higher scores indicating worse symptoms. Classes are mild (5-25), moderate (30-50), severe (55-75), and severe (80-100).
Time frame: 6 months post procedure
Population: All participants with 6-month NOSE scores
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Latera Implant | The Primary Efficacy Endpoint is the Percent of Treatment Responders | 101 Participants |
Secondary
Change in Nasal Airway Obstruction From Baseline Using the Visual Analog Scale (VAS).
Change from baseline in VAS score for ability to breathe through the nose. Participants provide scores on a scale of 0 (easy to breathe through the nose) to 100 (unable to breathe through the nose). Negative values for the change from baseline 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 (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Latera Implant | Change in Nasal Airway Obstruction From Baseline Using the Visual Analog Scale (VAS). | 1-Month FU | -40.4 score on a scale |
| Latera Implant | Change in Nasal Airway Obstruction From Baseline Using the Visual Analog Scale (VAS). | 3-Month FU | -46.3 score on a scale |
| Latera Implant | Change in Nasal Airway Obstruction From Baseline Using the Visual Analog Scale (VAS). | 6-Month FU | -45.6 score on a scale |
| Latera Implant | Change in Nasal Airway Obstruction From Baseline Using the Visual Analog Scale (VAS). | 24-Month FU | -51.0 score on a scale |
| Latera Implant | Change in Nasal Airway Obstruction From Baseline Using the Visual Analog Scale (VAS). | 12-Month FU | -47.5 score on a scale |
| Latera Implant | Change in Nasal Airway Obstruction From Baseline Using the Visual Analog Scale (VAS). | 18-Month FU | -48.7 score on a scale |
Secondary
Percent of Treatment Responders
Responder is defined as a participant who has improvement of at least 1 Nasal Obstruction Symptom Evaluation (NOSE) class or at least 20% NOSE score reduction. NOSE scores. NOSE scores can range from 5 to 100, with higher scores indicating worse symptoms. Classes are mild (5-25), moderate (30-50), severe (55-75), and severe (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 FU | 104 Participants |
| Latera Implant | Percent of Treatment Responders | 3-Month FU | 106 Participants |
| Latera Implant | Percent of Treatment Responders | 12-Month FU | 88 Participants |
| Latera Implant | Percent of Treatment Responders | 18-Month FU | 70 Participants |
| Latera Implant | Percent of Treatment Responders | 24-Month FU | 72 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 24 months post procedure
Population: All participants with follow-up beyond 6 months.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Latera Implant | Procedure and Device Related Adverse Events | 1 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 with satisfaction questionnaires completed at the 6-month follow-up.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Latera Implant | Subject Satisfaction Questionnaire | 89 Participants |