Versius Clinical Study in Robot Assisted Inguinal Hernia Repair Surgery

NCT07316517 | Not Yet Recruiting

• 1 other identifier: CA-00615
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Robotic Assisted Inguinal Hernia Repair

Keywords

Versius; Robotic surgery; Inguinal hernia

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (11)

• Operative time

  Up to completion of surgery

• Estimated blood loss

  Up to completion of surgery

• Intra-operative adverse events

  Up to completion of surgery

• Blood transfusion

  Up to completion of surgery

• Device deficiencies

  Up to completion 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: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• CMR Surgical Ltd: lead
• Division of General Oncologic and Minimally Invasive Surgery, Niguarda Hospital Milan: collaborator

Study Sites (1)

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

Milan, Italy

Location

MeSH Terms

Conditions

Hernia, Inguinal

Condition Hierarchy (Ancestors)

Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Bruno Domenico Antonio Alampi, MD

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

  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: December 5, 2025
• First Posted: January 5, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 5, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)