Robotic Assisted Inguinal Hernia RepairNCT07316517
Versius Clinical Study in Robot Assisted Inguinal Hernia Repair Surgery
A study testing Versius Surgical System in people with Robotic Assisted Inguinal Hernia Repair, run by CMR Surgical Ltd at 2 sites in 2 countries.
Trial summary
The objective of this clinical trial is to evaluate the safety and efficacy of Versius in Inguinal Hernia repair surgery Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Robotic Assisted Inguinal Hernia Repair
- What is being tested?
- Versius Surgical System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 22 Jul 2026to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
Diana Toderita, PhD contact
2 sites in 2 countries
Italy1 site, 1 recruiting
- Recruiting
Division of General Oncologic and Minimally Invasive Surgery, Niguarda Hospital Milan
Milan
Bruno Domenico Antonio Alampi, MD
Spain1 site, 1 recruiting
- Not yet recruiting
Bellvitge University Hospital
Barcelona
Jaime Lopez Borao, MD
About this study
Official title: 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
- Conditions
- Robotic Assisted Inguinal Hernia Repair
- Being tested
- Versius Surgical System
- Keywords
- Versius, Robotic surgery, Inguinal hernia
- Medical subject headings
- Hernia, Inguinal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Versius Surgical SystemDevice
Modular robotic system intended to assist in the accurate control of its surgical endoscopic instruments across a range of surgical procedures.
| Study group | Role | What they receive |
|---|---|---|
| Surgery with Versius | Experimental | Not described Receives: Device: Versius Surgical System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success rate
Rate of successful completion of robotic assisted surgery as planned without unplanned conversion to other laparoscopic or open surgery
Measured: Up to completion of surgery
Serious Adverse Event rate
Rate of total procedure related serious adverse events
Measured: Up to 30 days post procedure
Secondary outcomes (11)
Operative time
Surgical time from skin incision to skin closure
Measured: Up to completion of surgery
Estimated blood loss
Amount of blood estimated to be lost during surgery (in mL)
Measured: Up to completion of surgery
Intra-operative adverse events
Adverse events that occur during surgery
Measured: Up to completion of surgery
Blood transfusion
Need for blood transfusion during surgery as well as amount transfused
Measured: Up to completion of surgery
Device deficiencies
Any device deficiencies of Versius during surgery
Measured: Up to completion of surgery
Reoperation within 24 hours
Need for reoperation after initial surgery
Measured: 24 hours post-surgery
Length of hospital stay
Hospital stay in days from day of surgery until discharge
Measured: 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
Measured: Up to 30 days post-surgery
Readmission
Hospital readmission after post-surgical discharge
Measured: 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
Measured: Up to 30 days post-surgery
Mortality rate
Measured: Up to 30 days post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2026
- Study start22 Jul 2026
- Primary completionNov 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Robotic Assisted Inguinal Hernia RepairStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CMR Surgical Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Hospital Universitari de Bellvitge, Niguarda Hospital
- Responsible party
- Sponsor
- Investigators
- Bruno Domenico Antonio Alampi, MD, Principal investigator, Division of General Oncologic and Minimally Invasive Surgery, Niguarda Hospital MilanJaime Lopez Borao, MD, Principal investigator, Hospital Universitari de Bellvitge
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07316517
- Sponsor's protocol ID
- CA-00615
- Status last verified
- Sep 2026
- First submitted
- 5 Dec 2025
- Last updated
- 28 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Clinical Study to Evaluate the Safety and Efficacy of Versius in Robot-Assisted Inguinal Hernia Repair Surgery
- ClinicalTrials.gov ID
- NCT07316517
- Acronym / sponsor ID
- CA-00615
- Conditions
- Robotic Assisted Inguinal Hernia Repair
- Keywords
- Versius, Robotic surgery, Inguinal hernia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- CMR Surgical LtdIndustry (pharma, biotech, devices)
- Collaborators
- Hospital Universitari de Bellvitge, Niguarda Hospital
- Study start
- 22 Jul 2026 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 5 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this clinical trial is to evaluate the safety and efficacy of Versius in Inguinal Hernia repair surgery
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Surgery with Versius | Experimental | Device: Versius Surgical System |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Versius Surgical SystemModular robotic system intended to assist in the accurate control of its surgical endoscopic instruments across a range of surgical procedures. | Device | Surgery with Versius |
Primary outcome
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
Serious Adverse Event rate
Time frame: Up to 30 days post procedure
Rate of total procedure related serious adverse events
11 secondary outcomes
Operative time
Time frame: Up to completion of surgery
Estimated blood loss
Time frame: Up to completion of surgery
Intra-operative adverse events
Time frame: Up to completion of surgery
Blood transfusion
Time frame: Up to completion of surgery
Device deficiencies
Time frame: Up to completion of surgery
Reoperation within 24 hours
Time frame: 24 hours post-surgery
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
Adverse events
Time frame: Up to 30 days post-surgery
Readmission
Time frame: Up to 30 days post-surgery
Reoperation within 30 days
Time frame: Up to 30 days post-surgery
Mortality rate
Time frame: Up to 30 days post-surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for Robotic Assisted Inguinal Hernia Repair
Active, not recruiting
Medtronic Hugo™ Robotic Assisted Surgery (RAS) System in Hernia Surgery (Enable Hernia Repair)
Inguinal Hernia, Ventral Hernia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Diana Toderita, PhD contact
Bruno Domenico Antonio Alampi, MD principal investigator
Division of General Oncologic and Minimally Invasive Surgery, Niguarda Hospital Milan
Jaime Lopez Borao, MD principal investigator
Hospital Universitari de Bellvitge
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Versius Surgical System in people with Robotic Assisted Inguinal Hernia Repair, run by CMR Surgical Ltd at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mark Slack, MD (+44 7766 024389, mark.slack@cmrsurgical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success rate (time frame: Up to completion of surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2026.