NCT04795817已完成不适用
A Prospective Single Center Investigation of the da Vinci® SP™ Surgical System for Transoral Robotic Surgery (TORS) for Treatment of Obstructive Sleep Apnea (OSA)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Type 1 Polysomnography (PSG)
研究概览
简要总结
It is a prospective, single center, single-arm clinical study to enroll a maximum of 25 subjects.
详细描述
It is a prospective, single center, single-arm clinical study to enroll a maximum of 25 subjects. The objective of this study is to evaluate the clinical utility of the da Vinci® SP™ Surgical System, instruments and accessories in TORS benign base of tongue resection procedures for the treatment of moderate to severe OSA. da Vinci® SP™ Surgical System, instruments and accessories are the approved medical device product by MFDS (Ministry of Food and Drug Safety, Republic of Korea).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is between 18 and 80 years old
- •Subject with BMI ≤ 35
- •Subject with moderate to severe sleep apnea, defined as 15 or more AHI events/hour
- •Subject who has failed or is unable to tolerate CPAP therapy
- •Subject diagnosed with OSA due to redundant base of tongue tissue
- •Subject must be a suitable candidate for base of tongue resection surgery
- •Subject who is willing and able to provide written informed consent
- •Subject who is willing and able to comply with the study protocol requirements
排除标准
- •Subject with a poor mouth opening or trismus
- •Subject with evidence of any primary cancers or metastatic disease, other than skin cancers
- •Subject who has had a surgical resection and/or chemoradiation therapy for oropharyngeal cancer
- •Subject with congenital malformations in the larynx, throat or tongue
- •Subject with an American Society of Anesthesiologists (ASA) score of Grade 4 or above during preoperative evaluation
- •Subject for whom any additional surgeries are planned for OSA within the study period, after the surgery in which the da Vinci SP System was used
- •Subject who is mentally handicapped or with a psychological disorder or severe systemic illness, that would preclude compliance with study requirements or ability to provide informed consent
- •Subject is pregnant or suspected to be pregnant
结局指标
主要结局
Type 1 Polysomnography (PSG)
时间窗: 90-150 days after surgery
Type I PSG measurements demonstrating Apnea Hypopnea Index (AHI) reduction.
次要结局
- Postoperative hemorrhage(Intra-Operative Assessment)
- Blood transfusions(Intra-Operative Assessment)
- Length of hospital stay (LOS)(Admission to the hospital to discharge from the hospital (check out time), up to an approximate of one week)
- Change in Hypopnea index (HI)(Pre-operative Assessments & Post-Operative (3 months +60 days) Assessment)
- Change in Lowest oxygen saturation (LSAT)(Pre-operative Assessments & Post-Operative (3 months +60 days) Assessment)
- Change in Percent sleep time below 90 percent oxygen saturation (ST90)(Pre-operative Assessments & Post-Operative (3 months +60 days) Assessment)
- Change in Berlin Questionnaire(Pre-operative Assessments & Post-Operative (3 months, +60 days) Assessment)
- Change in Upper airway volume(Pre-operative Assessment, Post-operative (within 30days ±14 days from surgery) Assessment & Post-Operative (3 months, +60 days) Assessment)
- Robotic procedure time(Intra-Operative Assessment)
- Estimated blood loss (EBL)(Intra-Operative Assessment)
- Conversion rate(Intra-Operative Assessment)
- Change in Apnea index (AI)(Pre-operative Assessments & Post-Operative (3 months +60 days) Assessment)
- Change in Stanford Sleepiness Scale (SSS)(Pre-operative Assessments & Post-Operative (3 months, +60 days) Assessment)
- Change in MDADI (MD Anderson Dysphagia Inventory)(Pre-operative Assessments & Post-Operative (3 months, +60 days) Assessment)
- Total operative time(Intra-Operative Assessment)
- Volume of resected tissue(Immediately after surgery)
- Change in Percentages of sleep stages (N1, N2, N3, R)(Pre-operative Assessments & Post-Operative (3 months +60 days) Assessment)
- Change in Epworth Sleepiness Scale (ESS)(Pre-operative Assessments & Post-Operative (3 months +60 days) Assessment)
- Adverse Events (AE)(Through study conclusion (3 month follow up +60 days))
研究者
研究点 (1)
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