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

CMR Surgical Ltd · NCT07096856

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 22+ · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Not applicable
Target enrollment
100
US sites recruiting
2
Study start
March 23, 2026
Record last updated
September 11, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is 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.

Being studied: Robotic assisted cholecystectomy

Conditions: Cholecystectomy, Robotic

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

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

  • 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
  • Contraindication for undergoing surgery with Versius (Bleeding diathesis, Active pregnancy or BMI ≥40 kg/m2)

Recruiting US locations

  • Cedar-Sinai Heatlh Sciences University

    Los Angeles, CA 90048

    Site contact: Miguel Burch · 310-423-8350 · Miguel.Burch@csmc.edu

  • University of California San Diego Health

    San Diego, CA 92037

    Site contact: Ryan Broderick · 858-657-8860 · rbroderick@health.ucsd.edu

Study contacts (from the official record)

  • Morad Nakleh · +44 7746008535 · morad.naklheh@cmrsurgical.com
  • Martin Ramette · +447761631263 · martin.ramette@cmrsurgical.com
Post Market Clinical Study to Evaluate the Performance of the… (NCT07096856) | Bored Studies