Latera Randomized Controlled Trial (RCT) - Latera® Absorbable Nasal Implant vs. Sham Control for Lateral Nasal Valve Collapse
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Spirox, Inc.
- 入组人数
- 137
- 试验地点
- 11
- 主要终点
- NOSE Responder Rate
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
Participants will be masked to treatment assignment through the 3-month assessment period.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- 未提供
研究组 & 干预措施
Sham Control Arm
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.
干预措施: Latera Implant (Device)
Latera Treatment Arm
Subjects in the active treatment arm will receive the Latera Implant using standard techniques. Follow up continues for 24 months post-implant.
干预措施: Sham Procedure (Device)
结局指标
主要结局
NOSE Responder Rate
时间窗: 3 months postprocedure.
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.
次要结局
- Responder Rate(7 days, 30 days, and 6, 12, 18 and 24 months.)