Cholecystectomy, Robotic
Conditions
Brief 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.
Interventions
Robotic assisted cholecystectomy
Sponsors
CMR Surgical Ltd
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of successful completion of the cholecystectomy surgical procedure without unplanned conversions to open or other minimally invasive surgery | 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 |
| Rate of serious adverse events up to 30 days post procedure. | From end of surgery through 30 days post-procedure | Rate of serious adverse events up to 30 days post procedure. |
Countries
United States
Contacts
CONTACTMorad Nakleh
CONTACTMartin Ramette
PRINCIPAL_INVESTIGATORRyan Broderick
University of California San Diego Health
PRINCIPAL_INVESTIGATORMiguel Burch
Cedars-Sinai Health Sciences University
PRINCIPAL_INVESTIGATORErik Wilson
The University of Texas Health Science Center, Houston
Outcome results
None listed