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Purpose

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.

Condition

Eligibility

Eligible Ages
Over 22 Years
Eligible Sex
All
Accepts 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)

Study Design

Phase
N/A
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Robotic-Assisted Cholecystectomy Using the Versius Surgical System
  • Device: Robotic assisted cholecystectomy
    Robotic assisted cholecystectomy

Recruiting Locations

Cedar-Sinai Heatlh Sciences University
Los Angeles, California 90048
Contact:
Miguel Burch
310-423-8350
Miguel.Burch@csmc.edu

University of California San Diego Health
San Diego, California 92037
Contact:
Ryan Broderick
858-657-8860
rbroderick@health.ucsd.edu

More Details

Status
Recruiting
Sponsor
CMR Surgical Ltd

Study Contact

Morad Nakleh
+44 7746008535
morad.naklheh@cmrsurgical.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.