Versius Clinical Study in Robot Assisted Inguinal Hernia Repair Surgery

NCT ID: NCT07316517

Last Updated: 2026-01-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-03-31

Study Completion Date

2026-12-31

Brief Summary

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

Detailed Description

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Conditions

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Robotic Assisted Inguinal Hernia Repair

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Surgery with Versius

Group Type EXPERIMENTAL

Versius Surgical System

Intervention Type DEVICE

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

Interventions

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Versius Surgical System

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

Intervention Type DEVICE

Eligibility Criteria

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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).
Minimum Eligible Age

22 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

UNKNOWN

Sponsor Role collaborator

CMR Surgical Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bruno Domenico Antonio Alampi, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Milan, , Italy

Site Status

Countries

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Italy

Central Contacts

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Mark Slack, MD

Role: CONTACT

+44 7766 024389

Chad Schaber, PhD

Role: CONTACT

Other Identifiers

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CA-00615

Identifier Type: -

Identifier Source: org_study_id

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