Uniwersyteckie Centrum Kliniczne im. prof. K. Gibińskego Śląskiego Uniwersytetu Medycznego w Katowicach
Katowice, 40-572, Poland
Location status: Recruiting
Recruiting
NCT Number: NCT07289295
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
Recruiting
Interested in participating?
Request InfoKey information
Age range
22 year and older
Sex eligibility
Female
Study type
Interventional
Phase
Not applicable
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
Versius Surgical System
DeviceModular robotic system intended to assist in the accurate control of its surgical endoscopic instruments across a range of surgical procedures
Primary outcomes
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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
-
Operative time
Time frame: Day of surgery
Surgical time from skin incision to skin closure
-
Estimated blood loss
Time frame: Day of surgery
Amount of blood estimated to be lost during surgery (in mL)
-
Intra-operative complications
Time frame: Day of surgery
Complications that occur during surgery
-
Blood transfusions
Time frame: 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
Need for blood transfusion during or after surgery as well as amount transfused
-
Unplanned instrument use
Time frame: Day of surgery
Whether unplanned use of non-Versius laparoscopic instruments during surgery occurs as well as at what surgical step
-
Device deficiencies
Time frame: Day of surgery
Any device deficiencies of Versius during surgery
-
Reoperation within 24 hours
Time frame: 24 hours post-surgery
Need for reoperation after initial surgery
-
Length of hospital stay
Time frame: 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
Hospital stay in days from day of surgery until discharge
-
Adverse events
Time frame: Up to 30 days post-surgery
Rate of adverse events
-
Readmission
Time frame: Up to 30 days post-surgery
Hospital readmission after post-surgical discharge
-
Reoperation within 30 days
Time frame: Up to 30 days post-surgery
Need for reoperation as a result of interventional surgery itself or the indication for surgery
-
Mortality rate
Time frame: Up to 30 days post-surgery
-
Vaginal vault healing
Time frame: 42 days post-surgery
Vaginal vault healing as anticipated for patients that had total laparoscopic hysterectomy
Study contacts
Contact information is provided by the study sponsor or research team.
Chad Schaber, PhD
CONTACT
Mark Slack, MD
CONTACT
Sponsors and collaborators
Lead sponsor
CMR Surgical Ltd
Industry
Collaborators
- Uniwersyteckie Centrum Kliniczne im. prof. K. Gibińskego Śląskiego Uniwersytetu Medycznego w Katowicach
Registry information
Official study title
Prospective Clinical Study to Evaluate the Safety and Efficacy of Versius in Robot-Assisted Total Hysterectomy
Important dates
- Study start
- 2025
- Primary completion
- 2025
- Study completion
- 2026
- First posted
- Dec 17, 2025
- Registry last updated
- Dec 17, 2025
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.