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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Versius Surgical System
DeviceModular robotic system intended to assist in the accurate control of its surgical endoscopic instruments across a range of surgical procedures
Treatment groups
45 Participants
are divided into 1 treatment groupGroup A: Surgery with VersiusExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Success rate
Rate of successful completion of robotic assisted surgery without unplanned conversion to other laparoscopic or open surgery.
Time frame
Day of surgery2
Serious Adverse Event rate
Rate of total serious adverse events
Time frame
Up to 30 days post procedureSecondary outcomes
1
Operative time
Surgical time from skin incision to skin closure
Time frame
Day of surgery2
Estimated blood loss
Amount of blood estimated to be lost during surgery (in mL)
Time frame
Day of surgery3
Intra-operative complications
Complications that occur during surgery
Time frame
Day of surgery4
Blood transfusions
Need for blood transfusion during or after surgery as well as amount transfused
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 daysSponsors and contacts
Click on the lead sponsor to view all of their trials.
CMR Surgical Ltd
Lead sponsor
Uniwersyteckie Centrum Kliniczne im. prof. K. Gibińskego Śląskiego Uniwersytetu Medycznego w Katowicach
Collaborator
Source ClinicalTrials.gov