Not yet recruiting NCT07316517

Versius Clinical Study in Robot Assisted Inguinal Hernia Repair Surgery

No phase Interventional Robotic Assisted Inguinal Hernia Repair

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: Versius Surgical System.
Who it may be relevant to: Registry conditions: Robotic Assisted Inguinal Hernia Repair. Basic parameters: from 22 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: Italy
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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

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.

Secondary outcome measures (11)

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]

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.

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Italy · 1 center

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

NCT: NCT07316517 · CA-00615