Versius Clinical Study in Robot Assisted Inguinal Hernia Repair Surgery

Prospective Clinical Study to Evaluate the Safety and Efficacy of Versius 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

Study Overview

• Status: Not yet recruiting
• Conditions: Robotic Assisted Inguinal Hernia Repair
• Intervention / Treatment: Device: Versius Surgical System

• Study Type: Interventional
• Enrollment (Estimated): 30
• 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

• Italy
  • Milan, Italy
    • Division of General Oncologic and Minimally Invasive Surgery, Niguarda Hospital Milan
    • Principal Investigator: Bruno Domenico Antonio Alampi, MD

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. Patient unwilling to provide informed consent.
2. Medical contraindication for general anaesthesia or minimally invasive procedure.
3. Patient participation in an interventional clinical study that could impact primary outcomes results.
4. Patient who falls into American Society of Anaesthesiologists (ASA) Class IV or above.
5. Patients undergoing a concomitant surgical procedure.
6. Contraindication for undergoing surgery with Versius (bleeding diathesis, active pregnancy or BMI ≥40 kg/m2).

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 as planned without unplanned conversion to other laparoscopic or open surgery	Up to completion of surgery
Serious Adverse Event rate	Rate of total procedure related serious adverse events	Up to 30 days post procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Operative time	Surgical time from skin incision to skin closure	Up to completion of surgery
Estimated blood loss	Amount of blood estimated to be lost during surgery (in mL)	Up to completion of surgery
Intra-operative adverse events	Adverse events that occur during surgery	Up to completion of surgery
Blood transfusion	Need for blood transfusion during surgery as well as amount transfused	Up to completion of surgery
Device deficiencies	Any device deficiencies of Versius during surgery	Up to completion of surgery

Collaborators and Investigators

• Sponsor: CMR Surgical Ltd
• Collaborators: Division of General Oncologic and Minimally Invasive Surgery, Niguarda Hospital Milan
• Investigators: Principal Investigator: Bruno Domenico Antonio Alampi, MD, Division of General Oncologic and Minimally Invasive Surgery, Niguarda Hospital Milan

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: December 5, 2025
• First Submitted That Met QC Criteria: December 18, 2025
• First Posted (Actual): January 5, 2026

Study Record Updates

• Last Update Posted (Actual): January 5, 2026
• Last Update Submitted That Met QC Criteria: December 18, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Inguinal hernia; Robotic surgery; Versius
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Hernia; Hernia, Abdominal; Pathological Conditions, Signs and Symptoms; Hernia, Inguinal
• Other Study ID Numbers: CA-00615

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