Versius Clinical Study in Robot Assisted Inguinal Hernia Repair Surgery

CMR Surgical

Status: Begins enrollment this month

Conditions: Robotic Assisted Inguinal Hernia Repair

Treatments: Device: Versius Surgical System

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT07316517

CA-00615

Details and patient eligibility

About

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

Enrollment: 30 estimated patients

Sex: All

Ages: 22+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Surgery with Versius

Experimental group

Treatment:

Device: Versius Surgical System