Join us at Health Research Day — June 6th at Canton Waterfront Park, Baltimore!   Learn More →
← Back to all trials
Recruiting NCT07096856

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

Conditions: Cholecystectomy, Robotic

Sex: All
Ages: 22 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 100
Sponsor: CMR Surgical Ltd

Location: Cedar-Sinai Heatlh Sciences University Los Angeles California

Summary

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.

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)

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07096856). StuddyBuddy aggregates publicly available trial information.