OUS Multicenter Pilot Study of the CHILLS Cryotherapy System for the Treatment of Obstructive Sleep Apnea (ARCTIC-2)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Cryosa, Inc.
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- Incidence of Serious Procedure-Related Complications
研究概览
简要总结
This is a prospective, multicenter, non-randomized single-arm safety and efficacy study to:
- Collect data to evaluate the safety of CHILLS cryotherapy to treat OSA in patients with moderate to severe disease.
- Evaluate the chronic performance of the CHILLS system and collect clinical measures for therapy effectiveness that will be used to demonstrate safety and effectiveness in the next clinical study.
详细描述
The study will enroll up to 3 sites in Latin America, enrollment is competitive.
Up to 70 subjects will receive treatment and be followed through their 3-month visit.
Long-term follow-up will continue every 6 months out to 2 years post-procedure, with an option to follow patients up to 5 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 22 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Likely suffer moderate to severe OSA based on history and physical or have an established diagnosis of moderate to severe OSA (AHI ≥ 10) based on a prior sleep study.
- •A confirmation baseline sleep study will be performed after enrollment to verify AHI ≥ 10 and ≤ 50, and mixed and central apneas total ≤ 25% of apneas for continued eligibility.
- •Have either failed Positive Airway Pressure (PAP) therapy or decline PAP therapy
- •BMI of 25 - 40 kg/m2 at enrollment
- •Negative result for COVID-19 polymerase chain reaction (RT-PCR) test and absence of clinical symptoms for long COVID-19 relating to deterioration of taste, smell.
排除标准
- •Unable or incapable of providing informed written consent
- •Unwilling or incapable of returning to all follow-up visits and sleep studies, including evaluation procedures and filling out questionnaires
结局指标
主要结局
Incidence of Serious Procedure-Related Complications
时间窗: 90 Days
No serious procedure-related complications including death; loss of the airway requiring post-anesthesia care unit (PACU) re-intubation; persistent loss (more than 30 days) of tongue movement; bleeding requiring surgical intervention or transfusion; device- or procedure-related hospital re-admission; or De novo clinically significant hypoxemia (immediate or delayed) with SpO2 \< 70% for \> 10% of sleep.
次要结局
未报告次要终点