NCT06709261已完成不适用
EDS-2022-01: Safety and Performance of the OTTAVA™ Robotic System: A Prospective, Multi-Center Evaluation (FORTE)
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 6
- 主要终点
- Procedure completion without conversion to open surgery
研究概览
简要总结
This study assesses safety and performance of the OTTAVA Robotic System, through 30 days postoperative, in subjects undergoing robotic-assisted Roux-en-Y Gastric Bypass (RYGB) procedure.
研究设计
- 研究类型
- 干预性
- 分配方式
- 不适用
- 干预模型
- 单组
- 主要目的
- 治疗
- 盲法
- 开放（无盲法）
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- Criteria for Inclusion:
- Willing and able to provide informed consent;
- Scheduled for an elective primary RYGB surgical procedure;
- American Society of Anesthesiologists classification ≤ ASA III;
- Body habitus such that the procedure can be safely completed with OTTAVA Robotic System;
- Body weight <500 lb (227 kg);
- Patient presenting with class 2 or 3 obesity (BMI ≥ 35), regardless of comorbidities, or obesity with health risk satisfying 2022 ASMBS/IFSO indications for bariatric surgery; and
- A minimum of 21 years of age (at time of consent).
- Criteria for
排除标准
- Surgeon determination that there is a medical condition, that makes surgery too risky, including intraoperative finding;
- Concomitant surgical procedure including cholecystectomy (hiatal hernia repair up to 5 cm and adhesiolysis allowed);
- Upper abdominal surgery within two years prior to enrollment (prior laparoscopic cholecystectomy allowed);
- Evidence of hiatal hernia >5 cm (preoperative/intraoperative);
- Enrolled in another investigational study that may confound the results of this study;
- Emergency surgery;
- Active pregnancy; or
- Subject from a vulnerable population, including anyone unable to adequately provide informed consent.
研究组 & 干预措施
OTTAVA Robotic System
Experimental
Procedure with the OTTAVA Robotic System
干预措施: OTTAVA Robotic System (Device)
结局指标
主要结局
Procedure completion without conversion to open surgery
时间窗: Procedure day
Occurrence of intraoperative and postoperative device- or procedure-related complications
时间窗: Through 30 days post-procedure
次要结局
- Occurrence of all adverse events(Through 30 days post-procedure)
- Total operative time(Procedure day)
- Estimated blood loss(Procedure day)
- Occurrence of blood transfusion(Procedure day)
- Device malfunction details(Procedure day)
- Length of hospital stay(Hospital stay, assessed up to 30 days)
- Hospital readmission(Through 30 days)
- Reoperation(Through 30 days)
- Anastomotic leak(Through 30 days)
- Anastomotic stricture(Through 30 days)
- Mortality(Through 30 days)
研究者
研究点 (6)
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标识符
- NCT 编号
- NCT06709261
- 其他研究编号
- EDS-2022-01, EDS-2022-01
日期
- 首次提交
- (去年)
- 首次发布
- (去年)
- 主要完成日期
- (11个月前)
- 研究完成日期
- (11个月前)
- 最近核实
- (29天前)
- 最近更新
- (前天)
监管与共享
- FDA 监管药物
- 否
- FDA 监管器械
- 是
- 是否有结果
- 否
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