Carina™ Platform - A Single-arm Study for Gastrectomy
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Incidence of Serious Complications
研究概览
简要总结
To evaluate the safety and effectiveness of the laparoscopic surgical system（Carina™ Surgical Platform, developed by Ronovo Surgical, Inc) for use in gastrectomy.
详细描述
Source data verification: Cross-check between paper and electronic case report forms.
Standard Operating Procedures: The investigator is responsible for patient recruitment, while a independent statistician handles data collection and management. When source data is modified, changes must be traceable in both the electronic system and paper documents.
Statistical analysis plan: Categorical variables were analyzed using chi-square tests, while ordinal data were assessed using non-parametric tests. Continuous variables were analyzed using independent samples t-tests or non-parametric methods, as appropriate.
Handling of Missing Data: Missing data will be handled according to the classification of each dataset. For the Full Analysis Set (FAS), missing values for primary efficacy and safety endpoints will be imputed using the Worst Observation Carry Forward (WOCF) method, and considered as treatment failure or the occurrence of serious complications. No imputation will be performed for missing values in other datasets or for other secondary/exploratory endpoints.
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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 80 years, any gender
- •Patients with gastric cancer planned to undergo laparoscopic surgery assisted by the laparoscopic surgical system
- •Agree to participate in this study and voluntarily sign the informed consent form
- •Willing to cooperate with study follow-up and related examinations
排除标准
- •BMI < 18.5 kg/m² or BMI ≥ 30 kg/m²
- •Patients with severe cardiovascular diseases who cannot tolerate laparoscopic surgery
- •Patients with severe respiratory diseases who cannot tolerate laparoscopic surgery
- •Patients with severe coagulation disorders who cannot tolerate laparoscopic surgery
- •Patients with a history of abdominal or pelvic surgery, radiotherapy, or chemotherapy who are not suitable for laparoscopic surgery
- •Pregnant or breastfeeding women
- •Patients currently participating in other drug or medical device clinical trials
- •Patients deemed unsuitable for participation in this study by the investigator
结局指标
主要结局
Incidence of Serious Complications
时间窗: From the beginning of surgery until hospital discharge, up to 16 weeks
Any deviation from the expected postoperative recovery was considered an adverse event and was classified according to the Clavien-Dindo complication grading system. Only complications of grade III or above were included in the analysis.
Rate of No Surgical Conversion
时间窗: From the start of surgery to the end of surgery, up to 5 hours
No intraoperative conversion occurred from the robotic laparoscopic endoscopic surgical system-assisted procedure to another surgical instrument control system, conventional laparoscopy, or open surgery. The laparoscopic endoscopic surgical system is a medical device intended to assist the surgeon in accomplishing predefined surgical tasks. Completion of the remaining surgical procedures via laparoscopy or open surgery after the intended tasks have been performed using the system is not regarded as a conversion.
Incidence of Serious Complications
时间窗: From the beginning of surgery until hospital discharge, up to 16 weeks
Any deviation from the expected postoperative recovery was considered an adverse event and was classified according to the Clavien-Dindo complication grading system. Only complications of grade III or above were included in the analysis.
Rate of No Surgical Conversion
时间窗: From the start of surgery to the end of surgery, up to 5 hours
No intraoperative conversion occurred from the robotic laparoscopic endoscopic surgical system-assisted procedure to another surgical instrument control system, conventional laparoscopy, or open surgery. The laparoscopic endoscopic surgical system is a medical device intended to assist the surgeon in accomplishing predefined surgical tasks. Completion of the remaining surgical procedures via laparoscopy or open surgery after the intended tasks have been performed using the system is not regarded as a conversion.
次要结局
- Incidence of Device-Related Adverse Events and Serious Adverse Events(From the beginning of surgery until hospital discharge, up to 16 weeks)
- Pain Score(Pain assessments were performed twice: once at 24 hours after surgery and once prior to hospital discharge.)
- Intraoperative Physiological Load Assessment of the Surgeon(An assessment was conducted immediately upon completion of the surgical procedure.)
- Postoperative Length of Hospital Stay(Perioperative)
- Intraoperative Transfusion Rate(During surgery)
- Intraoperative Blood Loss(During surgery)
- System Setup Time(During surgery)
- Incidence of System Serious Failures(During surgery)
- Instrument Performance Evaluation(An assessment was conducted immediately upon completion of the surgical procedure.)
- Instrument Defects(From the start of surgery to the end of surgery)
- Incidence of Device-Related Adverse Events and Serious Adverse Events(From the beginning of surgery until hospital discharge, up to 16 weeks)
- Postoperative Mortality Rate(Perioperative)
- Incidence of Postoperative Complications(From the beginning of surgery until hospital discharge, up to 16 weeks)
- Pain Score(Pain assessments were performed twice: once at 24 hours after surgery and once prior to hospital discharge.)
- Intraoperative Physiological Load Assessment of the Surgeon(An assessment was conducted immediately upon completion of the surgical procedure.)
- Incidence of System Repairable Failures(An assessment was conducted immediately upon completion of the surgical procedure.)
- Postoperative Length of Hospital Stay(Perioperative)
- Robot-Assisted Surgery Time(During surgery)
- Intraoperative Transfusion Rate(During surgery)
- Intraoperative Mental Workload Assessment of the Surgeon(An assessment was conducted immediately upon completion of the surgical procedure.)
- Intraoperative Blood Loss(During surgery)
- System Setup Time(During surgery)
- Incidence of System Serious Failures(During surgery)
- Instrument Performance Evaluation(An assessment was conducted immediately upon completion of the surgical procedure.)
研究者
zhouyanbing
Professor
The Affiliated Hospital of Qingdao University