Actively Recruiting
Versius Gynecology Study
Led by CMR Surgical Ltd · Updated on 2025-12-17
45
Participants Needed
1
Research Sites
22 weeks
Total Duration
On this page
Sponsors
C
CMR Surgical Ltd
Lead Sponsor
U
Uniwersyteckie Centrum Kliniczne im. prof. K. Gibińskego Śląskiego Uniwersytetu Medycznego w Katowicach
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Versius Gynecology Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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.
You will not qualify if you...
- 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.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Uniwersyteckie Centrum Kliniczne im. prof. K. Gibińskego Śląskiego Uniwersytetu Medycznego w Katowicach
Katowice, Poland, 40-572
Actively Recruiting
Research Team
M
Mark Slack, MD
CONTACT
C
Chad Schaber, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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