Versius robotic system for total hysterectomy and salpingo-oophorectomy

Prospective Clinical Study to Evaluate the Safety and Efficacy of Versius in Robot-Assisted Total Hysterectomy

This study will test the Versius robotic surgical system in women having a total minimally invasive hysterectomy and/or salpingo‑oophorectomy for benign conditions.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 45 (estimated)
• Ages: 22 Years and up
• Sex: Female
• Sponsor: CMR Surgical Ltd (Industry-sponsored)
• Locations: 1 site (Katowice)
• Trial ID: NCT07289295 on ClinicalTrials.gov

What this trial studies

This interventional trial uses the Versius Surgical System to perform total robotic-assisted hysterectomy and/or salpingo‑oophorectomy for benign gynecologic conditions. Eligible participants are adult women (≥22 years) with BMI ≤40 who are suitable for minimally invasive surgery and have a uterus no larger than about 14 weeks' size; key exclusions include malignancy, severe comorbidity, uncontrolled hypertension or diabetes, and ASA Class IV or higher. The primary objective is to expand clinical data on the safety and efficacy of the Versius system by collecting perioperative outcomes, complication rates, and procedure feasibility at a single university clinical center. Procedures are performed under general anaesthesia by trained surgical teams using the Versius platform, with follow-up to capture recovery and any adverse events.

Who should consider this trial

Good fit: Ideal candidates are women aged 22 or older with benign gynecologic conditions who are eligible for minimally invasive total hysterectomy and/or salpingo‑oophorectomy, have BMI ≤40, and a uterus no larger than about 14 weeks.

Not a fit: Patients with malignant disease, very large uteri (>14 weeks), uncontrolled comorbidities, ASA Class IV or higher, or who cannot undergo general anaesthesia are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, the Versius system could offer a minimally invasive option with comparable or improved safety and shorter recovery compared with more invasive approaches.

How similar studies have performed: Robotic-assisted hysterectomy is well established with other robotic platforms, and early feasibility work with Versius has shown comparable safety and feasibility, though larger comparative data are limited.

Eligibility criteria

Inclusion Criteria:

1. Female, aged 22 years or above, who provided written informed consent to participate in the study.
2. Patient deemed suitable for minimally invasive total hysterectomy and/or Salpingo-Oophorectomy, for benign condition.
3. Patient with BMI ≤40.

Exclusion Criteria:

1. Patient unwilling to provide informed consent.
2. Medical contraindication for general anaesthesia or minimally invasive procedure.
3. Oncological cases, patient undergoing surgery or treatment for malignant disease.
4. Clinically assessed Uterus size of \> 14 pregnancy weeks (Estimated as \> 14-15 cm longitudinal diameter).
5. Patient participation in an interventional clinical study that could impact primary outcomes results.
6. Patient who falls into American Society of Anaesthesiologists (ASA) Class IV or above (Appendix A).
7. Uncontrolled hypertension, uncontrolled diabetes mellitus, or kidney failure.

Where this trial is running

Katowice

• Uniwersyteckie Centrum Kliniczne im. prof. K. Gibińskego Śląskiego Uniwersytetu Medycznego w Katowicach — Katowice, Poland (Recruiting)

Study contacts

• Principal investigator: Krzysztof Nowosielski, MD — Uniwersyteckie Centrum Kliniczne im. prof. K. Gibińskego Śląskiego Uniwersytetu Medycznego w Katowicach
• Study coordinator: Mark Slack, MD

Conditions Robotic Assisted Hysterectomy and/or Salpingo-oophorectomy; Versius; robotic surgery; hysterectomy; salpingo-oophrectomy; gynecology