Versius Gynecology Study

NCT07289295 | Recruiting

• 1 other identifier: CA-00574
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Robotic Assisted Hysterectomy and/or Salpingo-oophorectomy

Keywords

Versius; robotic surgery; hysterectomy; salpingo-oophrectomy; gynecology

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (13)

• Operative time

  Day of surgery

• Estimated blood loss

  Day of surgery

• Intra-operative complications

  Day of surgery

• Blood transfusions

  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

  Day of surgery

Study Arms (1)

Surgery with Versius

EXPERIMENTAL

Device: Versius Surgical System

Interventions

Versius Surgical System DEVICE

Modular robotic system intended to assist in the accurate control of its surgical endoscopic instruments across a range of surgical procedures

Surgery with Versius

Eligibility Criteria

• Age: 22 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• CMR Surgical Ltd: lead
• Uniwersyteckie Centrum Kliniczne im. prof. K. Gibińskego Śląskiego Uniwersytetu Medycznego w Katowicach: collaborator

Study Sites (1)

Uniwersyteckie Centrum Kliniczne im. prof. K. Gibińskego Śląskiego Uniwersytetu Medycznego w Katowicach

Katowice, 40-572, Poland

RECRUITING

Study Officials

• Krzysztof Nowosielski, MD

  Uniwersyteckie Centrum Kliniczne im. prof. K. Gibińskego Śląskiego Uniwersytetu Medycznego w Katowicach

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mark Slack, MD

CONTACT

+44 7766 024389; mark.slack@cmrsurgical.com

Chad Schaber, PhD

CONTACT

chad.schaber@cmrsurgical.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2025
• First Posted: December 17, 2025
• Study Start: July 25, 2025
• Primary Completion: December 1, 2025
• Study Completion: January 1, 2026
• Last Updated: December 17, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)