Mantra Multi Arm Surgical Robotic System - Clinical Study

Phase 1

Completed

• Conditions: Health Condition 1: O- Medical and Surgical

• Registration Number: CTRI/2020/11/029053
• Lead Sponsor: Robosurg Med Tech Pvt Ltd SS Innovations Group Company

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2022-05-23
• Last Update Posted: 17 October 2022

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 12

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

�Patients who have participated in another investigational clinical study within thirty (30) days before screening

�Inability to provide informed consent

�Uncontrolled hypertension, diabetes mellitus or any other co-morbidity 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1 System tasks could be performed safely on predefined procedures. <br/ ><br>2 System tasks required for performance of predetermined procedures <br/ ><br>3 System tasks required for feasible and could be carried out effectively. <br/ ><br>4 Device related adverse events <br/ ><br>Timepoint: Day of surgery till end of study

Secondary Outcome Measures

Name	Time	Method
Ease of the system by surgeons and operating room staff. <br/ ><br>Histopathology to see the clinical-pathological outcomes which will be compared with historical controls <br/ ><br>Operative time ââ?¬â?? from incision to skin closure <br/ ><br>Return to operating room within 24 hours of surgery <br/ ><br>Blood loss during the surgery <br/ ><br>Length of hospital stay <br/ ><br>Rate of hospital re admission after discharge (Noted during entire duration of study) <br/ ><br>Adverse events during the follow-up period per protocol. <br/ ><br>Timepoint: Day of surgery till end of study