Latera RCT - Latera vs. Sham Control for Lateral Nasal Valve Collapse

Study Overview
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Brief Summary
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The primary objective of the LATERA RCT is to demonstrate the superiority of the Latera Implant to improve nasal breathing, compared with a Sham Control procedure.

Detailed Description
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To evaluate the Latera Absorbable Nasal Implant (Latera Implant) Implant versus Sham Control in subjects with nasal valve collapse due to or primarily due to insufficient cartilaginous support of the lateral nasal wall.

Official Title
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Latera Randomized Controlled Trial (RCT) - Latera® Absorbable Nasal Implant vs. Sham Control for Lateral Nasal Valve Collapse

Conditions
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Nasal Valve Collapse, Nasal Breathing

Intervention / Treatment
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* Device: Latera Implant
* Device: Sham Procedure


Participation Criteria
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Eligibility Criteria
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Subjects must meet the following criteria to be included in the study: Adults aged 18 and above; Understands and provides written informed consent; Stated willingness to comply with all study procedures, post-treatment care and availability for the duration of the study follow up of 2 years; In good general health as evidenced by medical history; NOSE score ≥55; Dynamic bi-lateral nasal wall insufficiency as confirmed by Positive Modified Cottle Maneuver; Nasal and facial anatomy appropriate to receive the Latera Implant; Documented failure of benefit after at least 4 weeks of conservative medical management, including, for example, antihistamines or nasal steroids, evidenced by lack of efficacy or tolerability. Subjects meeting any one of the following criteria will be excluded for the study: Unable to tolerate or not a candidate for procedures performed under local anesthesia; Pathology other than lateral wall insufficiency (e.g. septal deviation, turbinate or adenoid hypertrophy, polyps, sinusitis, rhinitis) is the primary contributor to airway obstruction; Requires or is anticipated to require any other concurrent nasal procedures (e.g. Functional Endoscopic Sinus Surgery (FESS), rhinoplasty, sinuplasty, septoplasty, or turbinate reduction) outside of the index procedure within 12 months after the index procedure; FESS, sinuplasty, septoplasty, inferior turbinate reduction, or rhinoplasty within the past 6 months; Any other rhinoplasty procedures are planned or planned usage of external dilators within 24 months after the index procedure; Permanent nasal implant of any type (e.g. autologous, homologous, or synthetic graft) or dilator; Presence of concomitant inflammatory or infectious conditions or unhealed wounds in the treatment area (e.g., vestibulitis, vasculitis, active acne), Currently using chronic systemic steroids or recreational intra-nasal drugs; Currently has cancerous or pre-cancerous nasal lesions, has had radiation in the treatment area, or is currently receiving chemotherapy; History of a significant healing disorders including hypertrophic scarring, or keloid formation; Poorly controlled diabetes mellitus; Known or suspected allergy to PLA or other absorbable implant materials in the Latera Implant; Severe obstructive sleep apnea (OSA) and cannot or is unwilling to refrain from continuous positive airway pressure (CPAP) for up to 2 weeks post-procedure based on expected healing needs and mask types, in agreement with the treating physician; Female subjects, of child bearing potential, known or suspected to be pregnant or are lactating; Any other presenting condition that, in the medical opinion of the investigator, would disqualify the subject from the study.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Sham procedure participants will be allowed to crossover to receive Latera implants after the 3-month assessment if they continue to meet eligibility criteria. Crossover participants will be followed through 24 months post implant. Sham participants who do not crossover will be exited after the 3-month assessment.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Sham Control Arm<br>Subjects in the Sham Control arm will undergo the same preoperative assessments as those in the Latera Treatment arm up to and including anesthesia for the implant, however, no implant will be placed. Crossover - Subjects will be unblinded after the 3-month assessment is complete. Eligible subjects in the Sham Control arm will be treated with the Latera Implant if they still meet all eligibility criteria. Follow up will continue to 24 months post-implant. Subjects who no longer meet the eligibility criteria will exit the study. | Device: Latera Implant<br>* Treatment with implant<br>|
| Experimental: Latera Treatment Arm<br>Subjects in the active treatment arm will receive the Latera Implant using standard techniques. Follow up continues for 24 months post-implant. | Device: Sham Procedure<br>* Sham procedure where the Latera delivery device is inserted but no implant delivered.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NOSE Responder Rate | The primary endpoint of the study is the NOSE Responder Rate, assessed 3 months post-procedure in the per-protocol population of the Latera and Sham arms. The Nasal Obstruction Symptom Evaluation (NOSE) is a validated patient-reported outcome assessment of 5 questions relating to nasal obstruction (congestion, obstruction, trouble breathing through the nose, trouble sleeping, unable to breath through the nose during exercise/exertion. Each question is rated on a Likert scale of 0 (no problem) to 4 (severe problem). The sum of the scores is multiplied by 5 to result in a total score that ranges from 0 to 100. NOSE scores can also be categorized as mild (5-25), moderate (30-50), severe (55-75), and extreme (80-100). A NOSE responder is defined as a participant with at least 1 NOSE class improvement or at least 20% total NOSE score reduction. | 3 months postprocedure. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Responder Rate | Responder Rate at 7 days, 30 days, and 6, 12, 18 and 24 months will be assessed | 7 days, 30 days, and 6, 12, 18 and 24 months. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Polylactide absorbable implant, nasal airway obstruction, sham-control