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RECRUITING Not applicable ClinicalTrials.gov

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

Sponsor: CMR Surgical Ltd • ClinicalTrials.gov ID: NCT07096856

Registry updated: 2026-09-11
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Description

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.

Interventions

  • Robotic assisted cholecystectomy (Device)
    Robotic assisted cholecystectomy

Eligibility 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)

Conditions

Cholecystectomy, Robotic

Locations

  • Cedar-Sinai Heatlh Sciences University — Los Angeles, California, United States
  • University of California San Diego Health — San Diego, California, United States
  • University of Texas Health Science Center at Houston — Houston, Texas, United States
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record