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Clinical Trials/CTRI/2022/09/045789
CTRI/2022/09/045789
Not yet recruiting
Phase 2

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

CMR Surgical India Pvt Ltd0 sites0 target enrollmentTBD
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ConditionsHealth Condition 1: N948- Other specified conditions associated with female genital organs and menstrual cycle

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Health Condition 1: N948- Other specified conditions associated with female genital organs and menstrual cycle
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 total laparoscopic hysterectomy
  • •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\. Female, aged 18 years or above
  • •4\. Female of childbearing potential, must not be pregnant
  • •5\. Patients with BMI ââ?°Â¤40\. Ideally BMI ââ?°Â¥25 to ââ?°Â¤ 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)
  • •Class IV or above (Appendix B)
  • •5\. Uterus size of \> 14 weeks
  • •6\. History of chronic alcohol or drug abuse
  • •7\. Chronic renal failure or on dialysis

Outcomes

Primary Outcomes

Not specified

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