Join us at Health Research Day — June 6th at Canton Waterfront Park, Baltimore!   Learn More →
← Back to all trials
Completed NCT07289295

Versius Gynecology Study

Conditions: Robotic Assisted Hysterectomy and/or Salpingo-oophorectomy

Sex: Female
Ages: 22 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 46
Sponsor: CMR Surgical Ltd

Location: Uniwersyteckie Centrum Kliniczne im. prof. K. Gibińskego Śląskiego Uniwersytetu Medycznego w Katowicach Katowice

Summary

The objective of this clinical trial is to expand the clinical evaluation of the safety and efficacy of Versius in gynaecology procedures of total robotic assisted hysterectomy and/or salpingo-oophorectomy

Eligibility Criteria

Inclusion Criteria: 1. Female, aged 22 years or above, who provided written informed consent to participate in the study. 2. Patient deemed suitable for minimally invasive total hysterectomy and/or Salpingo-Oophorectomy, for benign condition. 3. Patient with BMI ≤40. Exclusion Criteria: 1. Patient unwilling to provide informed consent. 2. Medical contraindication for general anaesthesia or minimally invasive procedure. 3. Oncological cases, patient undergoing surgery or treatment for malignant disease. 4. Clinically assessed Uterus size of \> 14 pregnancy weeks (Estimated as \> 14-15 cm longitudinal diameter). 5. Patient participation in an interventional clinical study that could impact primary outcomes results. 6. Patient who falls into American Society of Anaesthesiologists (ASA) Class IV or above (Appendix A). 7. Uncontrolled hypertension, uncontrolled diabetes mellitus, or kidney failure.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07289295). StuddyBuddy aggregates publicly available trial information.