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Robot takes on hernia surgery in new safety trial

NCT ID NCT07316517

Disease control Sponsor: CMR Surgical Ltd Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study will test a robotic system called Versius in 30 adults having inguinal hernia repair surgery. The goal is to see if the robot is safe and works well, measuring things like how often the surgery is completed without switching to other methods, and any serious side effects. The robot helps the surgeon control instruments precisely during the procedure.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Versius Surgical System (a robotic device to assist surgeons during hernia repair)
What this could lead to
If successful, this could show that the Versius robot is a safe and effective tool for minimally invasive hernia repair, offering an alternative to traditional laparoscopic or open surgery.
What could go wrong
This is a small, early-stage study with only 30 participants, so results may not apply to everyone. There are always risks with surgery, such as infection or complications from anesthesia.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 30 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Mar 2026

An estimate. Start dates often move.

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

22 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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).

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Conditions

The condition(s) this trial relates to.

Hernia, Inguinal

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Robotic assisted inguinal hernia repair

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

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

    Milan, Italy