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

RecruitingNAAges 22 Years - anyAllCMR Surgical Ltd
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In plain words

What the trial is, and whether it could suit you

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 Com

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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 โ‰ฅ40 kg/m2)
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What it tests

  • Robotic assisted cholecystectomy
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Where

3 sites
Cedar-Sinai Heatlh Sciences University
Los Angeles, United States
University of California San Diego Health
San Diego, United States
University of Texas Health Science Center at Houston
Houston, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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