Versius-assisted inguinal hernia repair

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study evaluates the Versius Surgical System for robotic-assisted inguinal hernia repair. Eligible adults undergoing elective minimally invasive repair are treated with the Versius system, and outcomes related to safety and efficacy are collected. The study excludes those unable to consent, with contraindications to general anesthesia or MIS surgery, ASA IV or higher, concurrent procedures, or contraindications to Versius use. Primary results focus on feasibility, safety events, and short-term surgical performance in participating centers. Locations include Milan and Barcelona in collaboration with two hospitals.

Why it matters

Who can join: the full rules

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).

Where it's running

• Division of General Oncologic and Minimally Invasive Surgery, Niguarda Hospital Milan
  Milan, Italy Recruiting
• Bellvitge University Hospital
  Barcelona, Spain Not yet recruiting

Study contacts

• Principal investigator: Bruno Domenico Antonio Alampi, MD — Division of General Oncologic and Minimally Invasive Surgery, Niguarda Hospital Milan
• Study coordinator: Mark Slack, MD
• Email: mark.slack@cmrsurgical.com
• Phone: +44 7766 024389

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Versius robotic gallbladder removal: how well it works in adults

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.