NCT07289295
Recruiting
Not Applicable
Prospective Clinical Study to Evaluate the Safety and Efficacy of Versius in Robot-Assisted Total Hysterectomy
Overview
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- CMR Surgical Ltd
- Enrollment
- 45
- Locations
- 1
- Primary Endpoint
- Success rate
Overview
Brief 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
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 22 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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 Criteria
- •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.
Outcomes
Primary Outcomes
Success rate
Time Frame: Day of surgery
Rate of successful completion of robotic assisted surgery without unplanned conversion to other laparoscopic or open surgery.
Serious Adverse Event rate
Time Frame: Up to 30 days post procedure
Rate of total serious adverse events
Secondary Outcomes
- Estimated blood loss(Day of surgery)
- Operative time(Day of surgery)
- Intra-operative complications(Day of surgery)
- Blood transfusions(Up to post-surgical discharge, i.e. the date when patient is considered sufficiently recovered from surgery to leave hospital, expected to be at most up to 1 month after date of surgery, typically within a few days)
- Unplanned instrument use(Day of surgery)
- Device deficiencies(Day of surgery)
- Reoperation within 24 hours(24 hours post-surgery)
- Length of hospital stay(Up to post-surgical discharge, i.e. the date when patient is considered sufficiently recovered from surgery to leave hospital, expected to be at most up to 1 month after date of surgery, typically within a few days)
- Adverse events(Up to 30 days post-surgery)
- Readmission(Up to 30 days post-surgery)
- Reoperation within 30 days(Up to 30 days post-surgery)
- Mortality rate(Up to 30 days post-surgery)
- Vaginal vault healing(42 days post-surgery)
Investigators
Study Sites (1)
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