RecruitingNot ApplicableNCT07289295
Versius Gynecology Study
Prospective Clinical Study to Evaluate the Safety and Efficacy of Versius in Robot-Assisted Total Hysterectomy
Sponsor
CMR Surgical Ltd
Enrollment
45 participants
Start Date
Jul 25, 2025
Study Type
INTERVENTIONAL
Conditions
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
Sex: FEMALEMin Age: 22 Years
Inclusion Criteria3
- Female, aged 22 years or above, who provided written informed consent to participate in the study.
- Patient deemed suitable for minimally invasive total hysterectomy and/or Salpingo-Oophorectomy, for benign condition.
- Patient with BMI ≤40.
Exclusion Criteria7
- Patient unwilling to provide informed consent.
- Medical contraindication for general anaesthesia or minimally invasive procedure.
- Oncological cases, patient undergoing surgery or treatment for malignant disease.
- Clinically assessed Uterus size of \> 14 pregnancy weeks (Estimated as \> 14-15 cm longitudinal diameter).
- Patient participation in an interventional clinical study that could impact primary outcomes results.
- Patient who falls into American Society of Anaesthesiologists (ASA) Class IV or above (Appendix A).
- Uncontrolled hypertension, uncontrolled diabetes mellitus, or kidney failure.
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Interventions
DEVICEVersius Surgical System
Modular robotic system intended to assist in the accurate control of its surgical endoscopic instruments across a range of surgical procedures
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07289295