CTRI/2024/06/068556招募中Unknown
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. - NO
Sudhir Srivastava Innovations Pvt. Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- Unknown
- 状态
- 招募中
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
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
- •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.
研究者
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