Summary

Eligibility
for people ages 22 years and up (full criteria)
Location
at San Diego, California and other locations
Dates
study started
study ends around
Principal Investigator
by Ryan Broderick
Headshot of Ryan Broderick
Ryan Broderick

Description

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.

Keywords

Cholecystectomy, Robotic, Robotic assisted cholecystectomy, Robotic-Assisted Cholecystectomy Using the Versius Surgical System

Eligibility

You can join if…

Open to people ages 22 years and up

    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

You CAN'T join if...

  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)

Locations

  • University of California San Diego Health accepting new patients
    San Diego California 92037 United States
  • Cedar-Sinai Heatlh Sciences University accepting new patients
    Los Angeles California 90048 United States
  • University of Texas Health Science Center at Houston not yet accepting patients
    Houston Texas 77030 United States

Lead Scientist at UCSD

  • Ryan Broderick
    Associate Professor Of Clinical, Surgery, Vc-health Sciences-schools. Authored (or co-authored) 77 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
CMR Surgical Ltd
ID
NCT07096856
Study Type
Interventional
Participants
Expecting 100 study participants
Last Updated