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NCT Number: NCT07096856

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

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.

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Key information

Conditions

Cholecystectomy, Robotic

Age range

22 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Robotic assisted cholecystectomy

Device

Robotic assisted cholecystectomy

Primary outcomes

  1. 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 procedure

    Rate of successful completion of the cholecystectomy surgical procedure without unplanned conversions to open or other minimally invasive surgery

  2. Rate of serious adverse events up to 30 days post procedure.

    Time frame: From end of surgery through 30 days post-procedure

    Rate of serious adverse events up to 30 days post procedure.

Sponsors and collaborators

Lead sponsor

CMR Surgical Ltd

Industry

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 31, 2025
Registry last updated
Jul 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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