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Clinical Trials/CTRI/2022/08/045073
CTRI/2022/08/045073
Not yet recruiting
Phase 4

Prospective Clinical Study to Evaluate the Safety and Efficacy of the Versius Surgical System in Robot-Assisted Cholecystectomy

CMR Surgical India Pvt Ltd0 sites0 target enrollmentTBD
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Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Not specified
Sponsor
CMR Surgical India Pvt Ltd
Status
Not yet recruiting
Last Updated
3 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
3 years ago
Study Type
Interventional

Investigators

Sponsor
CMR Surgical India Pvt Ltd

Eligibility Criteria

Inclusion Criteria

  • •1\. Patient deemed suitable for laparoscopic Cholecystectomy
  • •procedure using Versius Surgical Robotic System
  • •2\. Patients able to provide written informed consent to
  • •participate in the study (with help of appropriate legal
  • •representatives if required)
  • •3\. Male and Female, aged 18 years or above
  • •4\. Female of childbearing potential, must not be pregnant and
  • •agree to not become pregnant for the duration of the study
  • •5\. Patients with BMI \<40\. Priority BMI 25 to 40

Exclusion Criteria

  • •1\. Patient participation in an investigational clinical study within 30 days before screening
  • •2\. Inability or difficulties to provide informed consent
  • •3\. Oncological cases, Patients undergoing surgery or treatment for malignant disease
  • •4\. Patients who fall into American Society of Anaesthesiologists (ASA) ClassIV or above
  • •5\. History of chronic alcohol or drug abuse
  • •6\. Chronic renal failure or on dialysis
  • •7\. Significant medical history or immunocompromised
  • •8\. Subjects with any other clinically significant unstable medical disorder, life\-threatening disease, or anything else in the opinion of the Investigator which would contra\-indicate a surgical procedure
  • •9\. Patient tested COVID positive within last 30 days of screening
  • •10\.Patient tested COVID positive within 48 hours day the of the procedure

Outcomes

Primary Outcomes

Not specified

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