Versius Gynecology Study

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

Study Overview

• Status: Recruiting
• Conditions: Robotic Assisted Hysterectomy and/or Salpingo-oophorectomy
• Intervention / Treatment: Device: Versius Surgical System

• Study Type: Interventional
• Enrollment (Estimated): 45
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mark Slack, MD; Phone Number: +44 7766 024389; Email: mark.slack@cmrsurgical.com
• Study Contact Backup: Name: Chad Schaber, PhD; Email: chad.schaber@cmrsurgical.com

Study Locations

• Poland
  • Katowice, Poland, 40-572
    • Recruiting
    • Uniwersyteckie Centrum Kliniczne im. prof. K. Gibińskego Śląskiego Uniwersytetu Medycznego w Katowicach
    • Contact: Main contact; Phone Number: +32 7894726; Email: knowosielski@sum.edu.pl
    • Principal Investigator: Krzysztof Nowosielski, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Surgery with Versius	Device: Versius Surgical System; Modular robotic system intended to assist in the accurate control of its surgical endoscopic instruments across a range of surgical procedures

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Success rate	Rate of successful completion of robotic assisted surgery without unplanned conversion to other laparoscopic or open surgery.	Day of surgery
Serious Adverse Event rate	Rate of total serious adverse events	Up to 30 days post procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Operative time	Surgical time from skin incision to skin closure	Day of surgery
Estimated blood loss	Amount of blood estimated to be lost during surgery (in mL)	Day of surgery
Intra-operative complications	Complications that occur during surgery	Day of surgery
Blood transfusions	Need for blood transfusion during or after surgery as well as amount transfused	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	Day of surgery
Device deficiencies	Any device deficiencies of Versius during surgery	Day of surgery
Reoperation within 24 hours	Need for reoperation after initial surgery	24 hours post-surgery
Length of hospital stay	Hospital stay in days from day of surgery until discharge	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	Up to 30 days post-surgery
Readmission	Hospital readmission after post-surgical discharge	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	Up to 30 days post-surgery
Mortality rate		Up to 30 days post-surgery
Vaginal vault healing	Vaginal vault healing as anticipated for patients that had total laparoscopic hysterectomy	42 days post-surgery

Collaborators and Investigators

• Sponsor: CMR Surgical Ltd
• Collaborators: Uniwersyteckie Centrum Kliniczne im. prof. K. Gibińskego Śląskiego Uniwersytetu Medycznego w Katowicach
• Investigators: Principal Investigator: Krzysztof Nowosielski, MD, Uniwersyteckie Centrum Kliniczne im. prof. K. Gibińskego Śląskiego Uniwersytetu Medycznego w Katowicach

Study record dates

Study Major Dates

• Study Start (Actual): July 25, 2025
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): January 1, 2026

Study Registration Dates

• First Submitted: July 30, 2025
• First Submitted That Met QC Criteria: December 4, 2025
• First Posted (Actual): December 17, 2025

Study Record Updates

• Last Update Posted (Actual): December 17, 2025
• Last Update Submitted That Met QC Criteria: December 4, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: hysterectomy; gynecology; robotic surgery; Versius; salpingo-oophrectomy
• Other Study ID Numbers: CA-00574

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No