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NCT Number: NCT07316517

Versius Clinical Study in Robot Assisted Inguinal Hernia Repair Surgery

The objective of this clinical trial is to evaluate the safety and efficacy of Versius in Inguinal Hernia repair surgery

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Key information

Conditions

Robotic Assisted Inguinal Hernia Repair Hernia Hernia, Abdominal Hernia, Inguinal Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

22 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Division of General Oncologic and Minimally Invasive Surgery, Niguarda Hospital Milan

Milan, Italy

Location contact

Bruno Domenico Antonio Alampi, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult patients 22 years of age and older, deemed eligible for elective minimal invasive inguinal Hernia repair surgery.
  • Patients providing written informed consent to participate in the study.

Exclusion criteria

  • Patient unwilling to provide informed consent.
  • Medical contraindication for general anaesthesia or minimally invasive procedure.
  • 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.
  • Patients undergoing a concomitant surgical procedure.
  • Contraindication for undergoing surgery with Versius (bleeding diathesis, active pregnancy or BMI ≥40 kg/m2).

Treatment and study plan

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.

Primary outcomes

  1. Success rate

    Time frame: Up to completion of surgery

    Rate of successful completion of robotic assisted surgery as planned without unplanned conversion to other laparoscopic or open surgery

  2. Serious Adverse Event rate

    Time frame: Up to 30 days post procedure

    Rate of total procedure related serious adverse events

Secondary outcomes

  1. Operative time

    Time frame: Up to completion of surgery

    Surgical time from skin incision to skin closure

  2. Estimated blood loss

    Time frame: Up to completion of surgery

    Amount of blood estimated to be lost during surgery (in mL)

  3. Intra-operative adverse events

    Time frame: Up to completion of surgery

    Adverse events that occur during surgery

  4. Blood transfusion

    Time frame: Up to completion of surgery

    Need for blood transfusion during surgery as well as amount transfused

  5. Device deficiencies

    Time frame: Up to completion of surgery

    Any device deficiencies of Versius during surgery

  6. Reoperation within 24 hours

    Time frame: 24 hours post-surgery

    Need for reoperation after initial surgery

  7. 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

    Hospital stay in days from day of surgery until discharge

  8. Adverse events

    Time frame: Up to 30 days post-surgery

    Rate of adverse events

  9. Readmission

    Time frame: Up to 30 days post-surgery

    Hospital readmission after post-surgical discharge

  10. Reoperation within 30 days

    Time frame: Up to 30 days post-surgery

    Need for reoperation as a result of interventional surgery itself or the indication for surgery

  11. Mortality rate

    Time frame: Up to 30 days post-surgery

Study contacts

Contact information is provided by the study sponsor or research team.

Chad Schaber, PhD

CONTACT

[email protected]

Mark Slack, MD

CONTACT

[email protected]

+44 7766 024389

Sponsors and collaborators

Lead sponsor

CMR Surgical Ltd

Industry

Collaborators

  • Division of General Oncologic and Minimally Invasive Surgery, Niguarda Hospital Milan

Registry information

Official study title

Prospective Clinical Study to Evaluate the Safety and Efficacy of Versius in Robot-Assisted Inguinal Hernia Repair Surgery

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jan 5, 2026
Registry last updated
Jan 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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