NL-OMON53885招募中4 期
Prospective non-randomised post-market study collecting clinical data on safety and effectiveness of the remed*®-System - r*ST Study
适应症
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •-Moderate to severe central sleep apnea (AHI >= 15 events per hour) based on a
- •sleep study scored by a local sleep laboratory. It is strongly recommended that
- •a patient have a diagnostic PSG within 12 months of the expected implant date
- •documenting moderate to severe CSA.
- •-Age 18 years or older
- •-Signed approved informed consent
- •-In the opinion of the investigator, subject is willing and able to comply with
- •the protocol.
- •-Not currently enrolled in another investigational study or registry that would
- •directly interfere with the current study, except if the subject is
- •participating in a mandatory government registry, or a purely observational
- •registry with no associated treatments. Each instance should be brought to the
- •attention of the sponsor to determine eligibility.
- •-In the opinion of the Investigator, life expectancy exceeds one year.
- •-The subject is not pregnant or planning to become pregnant.
排除标准
- •The subject is pregnant or planning to become pregnant
研究者
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