A prospective, multi-centre, non- randomised pilot clinical study to evaluate the safety, feasibility and efficacy of the multi arm robotic system- Mantra in the predetermined surgical procedures (STRS-Soft Tissue Robotic Surgeries) - STRS

Robosurg Med Tech Pvt Ltd SS Innovations Group Company0 个研究点目标入组 12 人开始时间: 待定最近更新: 2022年10月17日

试验速览

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•1 Male or Female patients with age of eighteen (18) and above.
•2 Able to give written informed consent.
•3 Patients meeting the inclusion criteria for one of the following surgical procedures using multi-arm robotic system for soft tissue surgeries:
•Cholecystectomy
•Hysterectomy
•Nephrectomy
•Prostatectomy
•Esophagus mobilization
•Internal Mammary Artery takedown
•Lung Lobectomy

•Ã¢â?¬Â¢Patients who have participated in another investigational clinical study within thirty (30) days before screening
•Ã¢â?¬Â¢Inability to provide informed consent
•Ã¢â?¬Â¢Uncontrolled hypertension, diabetes mellitus or any other co-morbidity that is considered as a high risk for the planned surgical procedure
•Ã¢â?¬Â¢Patients who fall into New York Heart Association (NYHA) Class
•Ã¢â?¬Â¢History of chronic alcohol or drug abuse.
•Ã¢â?¬Â¢Chronic renal failure or on dialysis.
•Ã¢â?¬Â¢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.

发起方

Robosurg Med Tech Pvt Ltd SS Innovations Group Company