Versius Gynecology Study
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
| Condition(s) | Robotic Assisted Hysterectomy and/or Salpingo-oophorectomy |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| 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 |
| Who can participate | 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 |
| Ages | 22 Years |
| Sex | Female |
| Lead sponsor | CMR Surgical Ltd |
| Locations | Katowice, Poland |
| Start date | 2025-07-25 |
| NCT ID | NCT07289295 |
| Official listing | https://clinicaltrials.gov/study/NCT07289295 |