Technology Evaluation in a Multi-Center Study of Safety and Performance of the OTTAVA System
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 4
- 主要终点
- Number of Participants Achieving Procedure Completion Without Conversion
研究概览
简要总结
The purpose of this study is to assess safety and performance of the OTTAVA System, through 30 days postoperative, in participants undergoing robotic-assisted inguinal hernia repair (IHR).
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must satisfy all inclusion criteria to be eligible for enrollment:
- •Willing and able to provide informed consent
- •A minimum of 22 years old at time of consent
- •Scheduled for elective primary inguinal hernia repair
- •American Society of Anesthesiologists (ASA) classification I, II, or III
- •Weight less than 227 kilograms (500 pounds)
排除标准
- •Subjects who meet any of the exclusion criteria may not be enrolled:
- •Physician determination, including intraoperative finding, that subject is a poor candidate for robotic surgery
- •Scheduled concomitant surgical procedure, other than lysis of adhesions, groin hernia repair, or umbilical or epigastric hernia repair not requiring mesh
- •Previous ipsilateral minimally invasive inguinal hernia repair (laparoscopic or robotic)
- •Previous radical prostatectomy procedure or pelvic irradiation
- •Hernia with significant scrotal involvement
- •Emergency surgery
- •Enrolled in another investigational study that may confound the results of this study
- •Currently pregnant or will be pregnant at time of procedure
- •Subject from a vulnerable population, including anyone unable to adequately provide informed consent.
研究组 & 干预措施
OTTAVA Robotic System
Participants scheduled to undergo a non-emergent inguinal hernia repair (IHR) procedure, and who meet all study eligibility criteria, will be enrolled to receive the IHR procedure with OTTAVA Robotic System. After the hospital discharge, participants will undergo follow-up visits according to the institution's standard of care and complete a final follow-up visit at 30 days post-procedure.
干预措施: OTTAVA Robotic System (Device)
结局指标
主要结局
Number of Participants Achieving Procedure Completion Without Conversion
时间窗: Intraoperative
Number of participants achieving procedure completion without conversion will be reported.
Number of Participants Experiencing Intraoperative and Postoperative Device or Procedure-Related Complications Greater than or Equal to (>=) Clavien-Dindo Grade III through 30 Days Post-Procedure
时间窗: Intraoperative through 30 days post-procedure
The Clavien-Dindo classification for surgical complications provides a standardized, reproducible means for describing surgical complications based on described therapy for treatment. Clavien-Dindo grade III complications include those complications that require surgical, endoscopic, or radiological intervention. The interventions that are not given under general anesthesia are grade III A and the interventions given under general anesthesia are grade III B complications.
次要结局
- Number of Participants with Adverse Events (AE) through 30 Days Post-Procedure(Up to 30 days post-procedure)
- Total Operative Time(Intraoperative)
- Number of Participants Needing Blood Transfusion(Intraoperative, Up to 30 days post-procedure)
- Number of Units of Blood Transfusion(Intraoperative, Up to 30 days post-procedure)
- Number of Participants Experiencing Device Malfunction(Intraoperative)
- Length of Hospital Stay(Intraoperative, Up to 30 days post-procedure)
- Number of Participants with Hospital Readmission(Up to 30 days post-procedure)
- Number of Participants with Reoperations(Up to 30 days post-procedure)
- Mortality(Intraoperative, Up to 30 days post-procedure)