A prospective non-randomised pilot clinical study to evaluate the safety, feasibility, and efficacy of MantraTM Surgical Robotic System, Model 3.0 in the predetermined surgical procedures.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- System tasks could be performed safely on predefined
研究概览
简要总结
This is a prospective data collection, non-randomized, pilot clinical study to assess the capability of MantraTM Surgical Robotic System, Model 3.0 to perform accurate surgical procedures.
The study shall be carried out at a single centre with total number of ten (10) patients that meet the criteria for inclusion.
The study duration is expected to be approximately two (2) months.
Meeting the inclusion criteria using MantraTM Surgical Robotic System, Model 3.0.
The study comprises of following visits:
Screening Visit (Visit 1)
Day of Surgery (Visit 2)
Day of Discharge (Visit 3)
Follow Visit (Visit 4)s
End of study Visit (Visit 5)
This study is registered with CTRI Number CTRI/2020/11/029053
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Male or Female patients with age of eighteen (18) and above.
- •Able to give written informed consent.
- •Patients meeting the inclusion criteria for one of the following surgical procedures using MantraTM Surgical Robotic System, Model 3.0 for soft tissue surgeries: Cholecystectomy Hysterectomy Nephrectomy Prostatectomy Oesophagus mobilization Internal Mammary Artery takedown Cystectomy Lung Lobectomy Nephron Sparing Surgery Bilateral Pelvic Lymph Node Dissection Radical Cystoprostatectomy Partial Nephrectomy.
排除标准
- •Patients who have participated in another investigational clinical study within thirty (30) days before screening Inability to provide informed consent Uncontrolled Comorbidities such as hypertension, diabetes mellitus or any other co-morbidities that is considered as a high risk for the planned surgical procedure Patients who fall into New York Heart Association (NYHA) Class III or IV History of chronic alcohol or drug abuse.
- •Chronic renal failure or on dialysis.
- •Subjects with any other clinically significant unstable medical condition, life-threatening disease, or anything else in the opinion of the Investigator that would contra-indicate a surgical procedure.
结局指标
主要结局
System tasks could be performed safely on predefined
时间窗: Procedure
procedures.
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System tasks required for the performance of predetermined
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System tasks required are feasible and could be carried out
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effectively.
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Device related adverse events.
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次要结局
- Ease of the system by surgeons and operating room staff.
研究者
Dr Prof Sudhir Kumar Rawal
Rajiv Gandhi Cancer Institute and Research Centre