Clinical trial Recruiting at 2 sites Interventional Ages 22 and up

Versius robotic gallbladder removal: how well it works in adults

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

Run by CMR Surgical Ltd · NCT07096856 · Data updated 2026-11-12

This study tests whether the Versius robotic system can safely and effectively perform gallbladder removal in adults without needing to switch to another method.

Quick facts

Study typeInterventional
Ages22 Years and up
SexAll
Enrollment100 (estimated)
SponsorCMR Surgical Ltd
Industry-sponsored
Locations3 sites (Los Angeles, California and 2 other locations)
StatusRecruiting
StartedMarch 23, 2026
Main results expectedMarch 30, 2027
Study endsApril 30, 2027
Registry record updatedSeptember 11, 2026
Trial IDNCT07096856 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adult patients 22 years and older who are candidates for minimally invasive gallbladder surgery and can consent to participate.

Probably not a fit

Patients who have conditions making them unsuitable for robotic-assisted surgery or who do not meet consent requirements may not benefit.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This post-market evaluation looks at the use of the Versius Surgical System for robotic-assisted cholecystectomy in adults. It collects data on technical success rates, 30-day safety outcomes, and patient recovery after surgery across several U.S. hospitals. Participants are adults 22 years or older undergoing minimally invasive gallbladder removal with Versius, with data gathered during the procedure and through a 30-day follow-up. The study aims to better understand device performance and real-world outcomes outside of controlled trials.

Why it matters

Potential benefit: If successful, the study could support broader use of the Versius system for gallbladder surgery and provide evidence on safety and recovery with robotic assistance.

How similar studies have gone: Prior studies of robotic cholecystectomy with similar systems have shown variable success; this study adds real-world pragmatic data for Versius.

Who can join: the full rules

Show full inclusion / exclusion 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:

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)

Where it's running

  • Cedar-Sinai Heatlh Sciences University
    Los Angeles, California, United States
    Recruiting
  • University of California San Diego Health
    San Diego, California, United States
    Recruiting
  • University of Texas Health Science Center at Houston
    Houston, Texas, United States
    Not yet recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.