Post Market Clinical Study to Evaluate the Performance of the Versius Surgical System
ConditionCholecystectomy, Robotic
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age22+
SponsorCMR Surgical Ltd
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Patient unwilling to provide informed consent
Patients undergoing surgery or treatment for malignant disease
Patients undergoing a concomitant surgical procedure
Medical contraindication for general anaesthesia or minimally invasive procedure
Trial design
Design model
Single group
Treatments tested in this trial
Robotic assisted cholecystectomy
DeviceRobotic assisted cholecystectomy
Treatment groups
100 Participants
are divided into 1 treatment groupGroup A: Robotic-Assisted Cholecystectomy Using the Versius Surgical SystemExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Rate of successful completion of the cholecystectomy surgical procedure without unplanned conversions to open or other minimally invasive surgery
Rate of successful completion of the cholecystectomy surgical procedure without unplanned conversions to open or other minimally invasive surgery
Time frame
From start of surgery to end of procedure2
Rate of serious adverse events up to 30 days post procedure.
Rate of serious adverse events up to 30 days post procedure.
Time frame
From end of surgery through 30 days post-procedureSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov