Versius Gynecology Study
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age22+
SponsorCMR Surgical Ltd
About this trial
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 criteria
Qualifiers
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.
Disqualifiers
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).
Trial design
Treatments tested in this trial
- Versius Surgical System
Treatment groups
45 Participants
are divided into 1 treatment groupSponsors and collaborators
CMR Surgical Ltd
Lead sponsor
Uniwersyteckie Centrum Kliniczne im. prof. K. Gibińskego Śląskiego Uniwersytetu Medycznego w Katowicach
Collaborator
Source ClinicalTrials.gov