CTRI/2020/11/029053
Completed
Phase 1
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 sites12 target enrollmentTBD
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Robosurg Med Tech Pvt Ltd SS Innovations Group Company
- Enrollment
- 12
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Not specified
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