跳至主要内容
临床试验/CTRI/2024/06/068556
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

发起方
Sudhir Srivastava Innovations Pvt. Ltd

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