Post Market Clinical Study to Evaluate the Performance of the Versius Surgical System

CMR Surgical

Status: Not yet enrolling

Conditions: Cholecystectomy, Robotic

Treatments: Device: Robotic assisted cholecystectomy

Study type: Interventional

Funder types: Industry

Identifiers

NCT07096856

CA-00583

Details and patient eligibility

About

The goal of this clinical trial is to learn how the Versius Surgical System, a robotic surgery device, works for gallbladder removal surgery (cholecystectomy) in adults. The main questions it aims to answer are:

How often can the surgery be successfully completed using Versius without needing to switch to a different surgical method?

What serious complications, if any, occur within 30 days after surgery?

Researchers will collect information from adult patients who have gallbladder surgery using the Versius system in U.S. hospitals. The purpose is to better understand how the device performs and how patients recover after surgery.

Participants will:

Be adults age 22 or older who are eligible for minimally invasive gallbladder surgery

Undergo robotic-assisted surgery using the Versius Surgical System

Allow the research team to collect data during surgery and up to 30 days after

Complete standard follow-up visits after discharge

Patients with certain medical conditions, such as cancer, high BMI (≥40 kg/m²), or contraindications to anesthesia or robotic surgery, will not be included in the study.

This study is sponsored by CMR Surgical Ltd., the manufacturer of the Versius system.

Enrollment: 100 estimated patients

Sex: All

Ages: 22+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 1. Adult patients 22 years of age and older, eligible for soft tissue minimal access surgery, for cholecystectomy 2. Patients providing written informed consent to participate in the study

Exclusion criteria

1. Patient unwilling to provide informed consent
2. Patients undergoing surgery or treatment for malignant disease
3. Patients undergoing a concomitant surgical procedure
4. Medical contraindication for general anaesthesia or minimally invasive procedure
5. 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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100 participants in 1 patient group

Robotic-Assisted Cholecystectomy Using the Versius Surgical System

Experimental group

Treatment:

Device: Robotic assisted cholecystectomy