Robotic Assisted Hysterectomy and/or Salpingo-oophorectomyNCT07289295
Versius Gynecology Study
A study testing Versius Surgical System in people with Robotic Assisted Hysterectomy and/or Salpingo-oophorectomy, run by CMR Surgical Ltd at 1 site in Poland.
Trial 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 Read more about this study
- Who is it for?
- Ages 22 years and older, women only
- Conditions the study is for
- Robotic Assisted Hysterectomy and/or Salpingo-oophorectomy
- What is being tested?
- Versius Surgical System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 sitePoland
- Study dates
- 25 Jul 2025to 14 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Poland1 site
Uniwersyteckie Centrum Kliniczne im. prof. K. Gibińskego Śląskiego Uniwersytetu Medycznego w Katowicach
Katowice, 40-572
About this study
Official title: Prospective Clinical Study to Evaluate the Safety and Efficacy of Versius in Robot-Assisted Total Hysterectomy
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
- Being tested
- Versius Surgical System
- Keywords
- Versius, robotic surgery, hysterectomy, salpingo-oophrectomy, gynecology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Versius Surgical SystemDevice
Modular robotic system intended to assist in the accurate control of its surgical endoscopic instruments across a range of surgical procedures
| Study group | Role | What they receive |
|---|---|---|
| Surgery with Versius | Experimental | Not described Receives: Device: Versius Surgical System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success rate
Rate of successful completion of robotic assisted surgery without unplanned conversion to other laparoscopic or open surgery.
Measured: Day of surgery
Serious Adverse Event rate
Rate of total serious adverse events
Measured: Up to 30 days post procedure
Secondary outcomes (13)
Operative time
Surgical time from skin incision to skin closure
Measured: Day of surgery
Estimated blood loss
Amount of blood estimated to be lost during surgery (in mL)
Measured: Day of surgery
Intra-operative complications
Complications that occur during surgery
Measured: Day of surgery
Blood transfusions
Need for blood transfusion during or after surgery as well as amount transfused
Measured: 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
Whether unplanned use of non-Versius laparoscopic instruments during surgery occurs as well as at what surgical step
Measured: Day of surgery
Device deficiencies
Any device deficiencies of Versius during surgery
Measured: Day of surgery
Reoperation within 24 hours
Need for reoperation after initial surgery
Measured: 24 hours post-surgery
Length of hospital stay
Hospital stay in days from day of surgery until discharge
Measured: 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
Rate of adverse events
Measured: Up to 30 days post-surgery
Readmission
Hospital readmission after post-surgical discharge
Measured: Up to 30 days post-surgery
Reoperation within 30 days
Need for reoperation as a result of interventional surgery itself or the indication for surgery
Measured: Up to 30 days post-surgery
Mortality rate
Measured: Up to 30 days post-surgery
Vaginal vault healing
Vaginal vault healing as anticipated for patients that had total laparoscopic hysterectomy
Measured: 42 days post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2025
- Study start25 Jul 2025
- Primary completion14 Apr 2026
- Study completion14 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Robotic Assisted Hysterectomy and/or Salpingo-oophorectomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- CMR Surgical Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Uniwersyteckie Centrum Kliniczne im. prof. K. Gibińskego Śląskiego Uniwersytetu Medycznego w Katowicach
- Responsible party
- Sponsor
- Investigators
- Krzysztof Nowosielski, MD, Principal investigator, Uniwersyteckie Centrum Kliniczne im. prof. K. Gibińskego Śląskiego Uniwersytetu Medycznego w Katowicach
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07289295
- Sponsor's protocol ID
- CA-00574
- Status last verified
- Sep 2026
- First submitted
- 30 Jul 2025
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Clinical Study to Evaluate the Safety and Efficacy of Versius in Robot-Assisted Total Hysterectomy
- ClinicalTrials.gov ID
- NCT07289295
- Acronym / sponsor ID
- CA-00574
- Keywords
- Versius, robotic surgery, hysterectomy, salpingo-oophrectomy, gynecology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- CMR Surgical LtdIndustry (pharma, biotech, devices)
- Collaborators
- Uniwersyteckie Centrum Kliniczne im. prof. K. Gibińskego Śląskiego Uniwersytetu Medycznego w Katowicach
- Study start
- 25 Jul 2025 (actual)
- Primary completion
- 14 Apr 2026 (actual)
- Study completion
- 14 Apr 2026 (actual)
- First posted
- 17 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Surgery with Versius | Experimental | Device: Versius Surgical System |
Who may qualify
- Ages
- 22 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Versius Surgical SystemModular robotic system intended to assist in the accurate control of its surgical endoscopic instruments across a range of surgical procedures | Device | Surgery with Versius |
Primary outcome
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
13 secondary outcomes
Operative time
Time frame: Day of surgery
Estimated blood loss
Time frame: Day of surgery
Intra-operative complications
Time frame: Day of 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
Unplanned instrument use
Time frame: Day of surgery
Device deficiencies
Time frame: Day of surgery
Reoperation within 24 hours
Time frame: 24 hours post-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
Adverse events
Time frame: Up to 30 days post-surgery
Readmission
Time frame: Up to 30 days post-surgery
Reoperation within 30 days
Time frame: Up to 30 days post-surgery
Mortality rate
Time frame: Up to 30 days post-surgery
Vaginal vault healing
Time frame: 42 days post-surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Krzysztof Nowosielski, MD principal investigator
Uniwersyteckie Centrum Kliniczne im. prof. K. Gibińskego Śląskiego Uniwersytetu Medycznego w Katowicach
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Versius Surgical System in people with Robotic Assisted Hysterectomy and/or Salpingo-oophorectomy, run by CMR Surgical Ltd at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success rate (time frame: Day of surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026.